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OpenTrials
Completed

NCT Number: NCT01212471

A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus 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

  • Be of either gender and any race 18 years or older

Exclusion criteria

  • Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Treatment and study plan

Bromfenac Ophthalmic Solution A

Drug

sterile ophthalmic solution

Bromfenac Ophthalmic Solution B

Drug

sterile ophthalmic solution

placebo comparator

Drug

sterile ophthalmic solution

Primary outcomes

  1. Mean Ocular Surface Disease Index (OSDI) Total Score

    Time frame: 42 days

    The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Sep 4, 2020

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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