NCT01109173

Confirmatory Study Nepafenac 0.3%

Clinical Evaluation of Nepafenac Ophthalmic Suspension, 0.3% for Prevention and Treatment of Ocular Inflammation and Pain After Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,120 (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 an investigational eye drop intended 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 dose 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 three times daily, for 16 days
OTHER	Nepafenac Ophthalmic Suspension 0.3% Vehicle	Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
OTHER	NEVANAC Vehicle	Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-01
• First posted: 2010-04-23
• Last updated: 2012-11-30
• Results posted: 2012-11-30

Locations

1 site across 1 country: United States