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OpenTrials
Completed

NCT Number: NCT00703781

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Completed

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for cataract surgery

Exclusion criteria

  • Known hypersensitivity to bromfenac and salicylates

Treatment and study plan

bromfenac ophthalmic solution

Drug

sterile ophthalmic solution

Placebo

Drug

sterile ophthalmic solution

Primary outcomes

  1. Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

    Time frame: Day 15

    Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)

Secondary outcomes

  1. Number of Participants That Are Pain Free

    Time frame: Day 1

    Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Jun 24, 2008
Registry last updated
Mar 24, 2015

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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