NCT01853072

Nepafenac Once Daily for Macular Edema - Study 1

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 881 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Proliferative Diabetic Retinopathy
• Cataract

Interventions

Type	Name	Description
DRUG	Nepafenac Ophthalmic Suspension, 0.3%	Test intervention
OTHER	Nepafenac vehicle	Inactive ingredients used as placebo comparator
DRUG	Prednisolone acetate	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

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-05-14
• Last updated: 2016-08-03
• Results posted: 2016-08-03