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CompletedNCT00333918Updated Feb 15, 2013

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

A Phase 3 interventional study of bromfenac ophthalmic solution and placebo comparator in Pain and Inflammation, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Bausch & Lomb Incorporated · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
522
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain
  • Inflammation

Keywords

  • Cataract Extraction
  • Anti-Inflammatory Agents, Non-Steroidal
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 522 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Known hypersensitivity to bromfenac and salicylates
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
522 participants (actual)

Study arms

  • Experimental
    1-bromfenac ophthalmic solution

    sterile ophthalmic solution

    Drug: bromfenac ophthalmic solution

  • Placebo comparator
    2-placebo comparator

    sterile ophthalmic solution

    Drug: placebo comparator

Interventions

  • Drugbromfenac ophthalmic solution
  • Drugplacebo comparator
06

What researchers measure

Primary outcomes

  1. Reduction of ocular inflammation

Secondary outcomes

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

07

Study locations

1 site
  • Irvine, California 92618, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00333918
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Jun 6, 2006
Start date
Jun 2006
Primary completion
Mar 2007
Completion
Mar 2007
Last update
Feb 15, 2013

Study contacts

Ralph Bianca, PhD
study director · ISTA Pharmaceuticals, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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