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OpenTrials
Completed

NCT Number: NCT00758784

Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

  • Subjects 18 years of age or older

Exclusion criteria

  • No active ocular conditions of disease

Treatment and study plan

bromfenac ophthalmic solution 0.06%

Drug

bromfenac ophthalmic solution 0.06% bilaterally twice a day

Primary outcomes

  1. Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye

    Time frame: Baseline, Day 42

    Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.

  2. Percentage of Participants With at Least One Adverse Event

    Time frame: 52 days

Secondary outcomes

  1. Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye

    Time frame: Baseline, 42 days

    Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Sep 14, 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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