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Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

NCT00198445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2013-03-14

No results posted yet for this study

Summary

The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.

Conditions

  • Postoperative Complications
  • Cataract

Interventions

DRUG

Bromfenac

One drop in study eye every 12 hours for 14 days

DRUG

Placebo

One drop in study eye every 12 hours for 14 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Lisa R Grillone, PhD · ISTA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2004-01-31
Completion
2004-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00198445 on ClinicalTrials.gov