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OpenTrials
Completed

NCT Number: NCT00853970

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Completed

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Key information

Conditions

Pain Inflammation Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • Male or female at least 18 years of age who are scheduled for unilateral cataract surgery

Exclusion criteria

  • Have known hypersensitivity to bromfenac or to any component of the investigational product

Treatment and study plan

bromfenac ophthalmic solution

Drug

sterile ophthalmic solution

placebo comparator

Drug

sterile ophthalmic solution

Primary outcomes

  1. Summed Ocular Inflammation Score (SOIS) of Zero

    Time frame: Day 15 (Primary Endpoint)

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

Secondary outcomes

  1. Pain Free

    Time frame: Day 1

    Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 2, 2009
Registry last updated
Jan 25, 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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