Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

Cataract Clinical Trial

Official title:

Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333255
• Other study ID #: C-04-41
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2006
• Last updated: July 7, 2009
• Start date: September 2005

Study information

• Verified date: July 2009
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

• Under 10

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Nepafenac Ophthalmic Suspension, 0.1%

Locations

Country	Name	City	State
United States	Lehmann Eye Center	Nacogdoches	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary	Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation