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
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