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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Nepafenac Ophthalmic Suspension, 0.1% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Andrew Maxwell, Study Director, Affiliation: Study Director

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.

Clinical Details

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

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

Primary outcome: 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 outcome: Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation

Eligibility

Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

- Under 10

Locations and Contacts

Lehmann Eye Center, Nacogdoches, Texas 76134, United States
Additional Information

Starting date: September 2005
Last updated: July 7, 2009

Page last updated: August 23, 2015

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