NCT01318499

Nepafenac 0.3% Two Study

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% Compared to Nepafenac Ophthalmic Suspension 0.1% and Vehicle for Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,342 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and efficacy of Nepafenac Ophthalmic Suspension, 0.3% for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Nepafenac Ophthalmic Suspension, 0.3%	Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
DRUG	Nepafenac Ophthalmic Suspension, 0.1%	Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
OTHER	Nepafenac Vehicle 0.3%	Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-03-18
• Last updated: 2012-12-17
• Results posted: 2012-12-17

Locations

1 site across 1 country: United States