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Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Inflammation

Intervention: bromfenac ophthalmic solution (Drug); placebo comparator (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Ralph Bianca, PhD, Study Director, Affiliation: ISTA Pharmaceuticals, Inc.

Summary

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

Clinical Details

Official title: Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Reduction of ocular inflammation

Secondary outcome: Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Scheduled for unilateral cataract surgery with no other ophthalmic surgical

procedures planned during cataract surgery

- Agree to return for all required visits

- Agree to avoid disallowed medications

Exclusion Criteria:

- Known hypersensitivity to bromfenac and salicylates

Locations and Contacts

Irvine, California 92618, United States
Additional Information

Starting date: June 2006
Last updated: February 13, 2013

Page last updated: August 20, 2015

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