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Completed

NCT Number: NCT00198445

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

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.

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Key information

Conditions

Postoperative Complications Cataract Eye Diseases Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harold A Helms, MD, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bromfenac

Drug

One drop in study eye every 12 hours for 14 days

Placebo

Drug

One drop in study eye every 12 hours for 14 days

Primary outcomes

  1. Ocular Inflammation Score

    Time frame: Visit 4 (Day 15)

    Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none

Secondary outcomes

  1. Mean Ocular Inflammation Score

    Time frame: At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22)

    Mean change from baseline in SOIS at each visit.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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