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OpenTrials
Completed

NCT Number: NCT01367249

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

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Key information

Conditions

Pain Cataract Eye Diseases Inflammation Lens Diseases 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

Drug

Sterile ophthalmic solution

Primary outcomes

  1. Ocular Inflammation

    Time frame: Day 15

    The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.

Secondary outcomes

  1. Ocular Pain

    Time frame: Day 1

    The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2011
Registry last updated
May 6, 2014

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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