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

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Bausch + Lomb

Status and phase

Completed
Phase 3

Conditions

Postoperative Complications
Cataract

Treatments

Drug: Placebo
Drug: Bromfenac

Study type

Interventional

Funder types

Industry

Identifiers

NCT00198445
ISTA-BR-CS001

Details and patient eligibility

About

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.

Enrollment

527 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cataract surgery
  • Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
  • Agreed to avoid disallowed medications (meds) throughout the duration of the study

Exclusion criteria

  • Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
  • Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
  • Extraocular/intraocular inflammation in either eye
  • Clinically significant (WHO CTC Grade 1 or greater) liver function tests

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

527 participants in 2 patient groups, including a placebo group

Bromfenac
Experimental group
Description:
Topical bromfenac ophthalmic solution 0.1%
Treatment:
Drug: Bromfenac
Placebo
Placebo Comparator group
Description:
Vehicle of bromfenac
Treatment:
Drug: Placebo

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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