Nevanac 3-Month Safety Study With QID Dosing

Phase 3

Completed

• Conditions: Cataract
• Interventions: Other: Nepafenac ophthalmic suspension vehicle; Drug: Nepafenac ophthalmic solution 0.1%; Drug: Ketorolac Tromethamine ophthalmic solution 0.4%

• Registration Number: NCT00332774
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Under 10
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Nepafenac ophthalmic suspension vehicle	-
Nevanac	Nepafenac ophthalmic solution 0.1%	-
Acular	Ketorolac Tromethamine ophthalmic solution 0.4%	-

Primary Outcome Measures

Name	Time	Method
Macular thickness

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Trial Locations

Locations (1)

Contact Alcon for Trial Locations; 🇺🇸 Fort Worth, Texas, United States