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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333918

Enrollment

522

Registered

2006-06-06

Start date

2006-06-30

Completion date

2007-03-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Pain

Keywords

Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal

Brief 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.

Interventions

DRUGbromfenac ophthalmic solution

DRUGplacebo comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction of ocular inflammation	—

Secondary

Measure	Time frame
Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026