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NCT Number: NCT02547623

Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or; * Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kislinger MD inc, Glendora, California, United States

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About this study

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

  • A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
  • Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • undergoing cataract surgery

Exclusion criteria

  • glaucoma patient, pregnancy, allergy to dexamethasone

Treatment and study plan

Dexamethasone

Drug

depot intracameral

Other names: Dexycu

Prednisolone

Drug

Prednisolone eye drops 1%

Other names: standard of care

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline to postoperative day 90/ early termination

    Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.

Secondary outcomes

  1. Intraocular Pressure Measurement

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

    Intraocular Pressure was measured by Goldmann applanation tonometry.

  2. Visual Acuity in Study Eye

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

    Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1

  3. Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.

    Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.

  4. Slit Lamp Biomicroscopy - Cornea Edema Grade

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.

    Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.

  5. Summary of Concomitant Medications Used in the Study Eye or Both Eyes

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  6. Changes in the Corneal Endothelial Cell Count

    Time frame: Baseline, Postoperative day 90/Early termination

    Corneal Endothelial Cell Density was measured by specular microscopy.

  7. Optic Disc Cup-disc Ratio for the Study Eye

    Time frame: Baseline, POD 90/Early termination

    Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).

  8. Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)

    Time frame: Baseline, POD 90/Early termination

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc

  9. Dilated Opthalmoscopy Findings - Retina (Study Eye)

    Time frame: Baseline, POD 90/Early termination

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina

  10. Dilated Opthalmoscopy Findings - Macula (Study Eye)

    Time frame: Baseline, POD 90/Early termination

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.

  11. Dilated Opthalmoscopy Findings - Choroid (Study Eye)

    Time frame: Baseline, POD 90/Early termination

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid

  12. Dilated Opthalmoscopy Findings - Vitreous (Study Eye)

    Time frame: Baseline, POD 90/Early termination

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous

Sponsors and collaborators

Lead sponsor

ICON Bioscience Inc

Industry

Registry information

Official study title

A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
Aug 21, 2018

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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