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Completed

NCT Number: NCT01193127

Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Competent and willing to voluntarily provide informed consent
  • 18 years of age or older
  • In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
  • Other inclusion criteria to be evaluated by the investigator

Exclusion criteria

  • No allergies to the medications and/or the active ingredients of any of the study medications
  • No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
  • No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
  • Other exclusion criteria to be evaluated by the investigator

Treatment and study plan

OMS302 Solution

Drug

OMS302 Mydriatic Solution

Drug

OMS302 Anti-inflammatory Solution

Drug

Balanced Salt Solution (BSS) Solution

Drug

Primary outcomes

  1. Pupil Diameter (mm) During Surgery

    Time frame: During surgery (immediately prior to surgical incision to wound closure)

    Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.

  2. Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively

    Time frame: through 12 hours post-surgery

    For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.

Secondary outcomes

  1. Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  2. Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  3. Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  4. Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  5. Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  6. Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  7. Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination

    Time frame: up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  8. Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  9. Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  10. Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  11. Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  12. Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  13. Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  14. Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination

    Time frame: Up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  15. Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  16. Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  17. Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  18. Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  19. Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  20. Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  21. Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination

    Time frame: Up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  22. Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  23. Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  24. Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  25. Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  26. Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  27. Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  28. Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination

    Time frame: Up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  29. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  30. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  31. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  32. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  33. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  34. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  35. Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination

    Time frame: Up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  36. Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery

    Time frame: Two hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  37. Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery

    Time frame: Six hours

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  38. Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery

    Time frame: One day

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  39. Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery

    Time frame: Two days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  40. Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery

    Time frame: Seven days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  41. Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery

    Time frame: 14 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  42. Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination

    Time frame: Up to 30 days

    The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  43. Best Corrected Visual Acuity (BVCA) - Log Score, Baseline

    Time frame: Baseline

    Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  44. Best Corrected Visual Acuity (BVCA) - Log Score, Day 1

    Time frame: One day

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  45. Best Corrected Visual Acuity (BVCA) - Log Score, Day 2

    Time frame: Two days

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  46. Best Corrected Visual Acuity (BVCA) - Log Score, Day 7

    Time frame: Seven days

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  47. Best Corrected Visual Acuity (BVCA) - Log Score, Day 14

    Time frame: 14 days

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  48. Best Corrected Visual Acuity (BVCA) - Log Score, Day 30

    Time frame: 30 days

    Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.

  49. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline

    Time frame: Baseline

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  50. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery

    Time frame: Two hours

    TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  51. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1

    Time frame: One day

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  52. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2

    Time frame: Two days

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  53. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7

    Time frame: Seven days

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  54. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14

    Time frame: 14 days

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  55. Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30

    Time frame: 30 days

    Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  56. Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline

    Time frame: Baseline

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  57. Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery

    Time frame: Two hours

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  58. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1

    Time frame: One day

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  59. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2

    Time frame: Two days

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  60. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7

    Time frame: Seven days

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  61. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14

    Time frame: 14 days

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  62. Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30

    Time frame: 30 days

    Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.

    Grading was as follows:

    Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.

    Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous

  63. Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery

    Time frame: Two hours

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  64. Postoperative Mean Anterior Chamber Cell Count, Day 1

    Time frame: One day

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  65. Postoperative Mean Anterior Chamber Cell Count, Day 2

    Time frame: Two days

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  66. Postoperative Mean Anterior Chamber Cell Count, Day 7

    Time frame: Seven days

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  67. Postoperative Mean Anterior Chamber Cell Count, Day 14

    Time frame: 14 days

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  68. Postoperative Mean Anterior Chamber Cell Count, Day 30

    Time frame: 30 days

    The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.

  69. Ocular Pain VAS Score After Day 0

    Time frame: 43 days

    VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.

  70. Postoperative Use of Ophthalmic Anti-inflammatory Medications

    Time frame: up to 30 days

    Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  71. Use of Pain Medications at Day 1

    Time frame: One day

    Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

  72. Use of Pain Medications After Day 1

    Time frame: up to 30 days

    Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.

Sponsors and collaborators

Lead sponsor

Omeros Corporation

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2010
Registry last updated
Aug 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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