Conditions: Non-Proliferative Diabetic Retinopathy Cataract
Keywords: Diabetes Type I Diabetes Type II non-proliferative diabetic retinopathy macular edema Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 881
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: With prednisolone acetate standard of care, Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery. arm 2: With prednisolone acetate standard of care, Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.

Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac vehicle intervention 3: Prednisolone acetate
Intervention descriptions: intervention 1: Test intervention intervention 2: Inactive ingredients used as placebo comparator intervention 3: 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

Protocol document: