Nepafenac Ophthalmic Suspension, 0.3%
DrugTest intervention
Other names: Nepafenac
NCT Number: NCT01853072
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Test intervention
Other names: Nepafenac
Inactive ingredients used as placebo comparator
1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
Other names: Omnipred™, Prednisolone acetate ophthalmic suspension
Time frame: Baseline to Day 14, and maintained through Day 90
BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.
Time frame: Day 0 to Day 90
Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.
Time frame: Baseline to Day 90
Time frame: Baseline to Day 60
Time frame: Day 7 up to any visit through Day 90
Time frame: Day 7 up to any visit through Day 90
Alcon Research
Industry
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
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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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