Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: bromfenac ophthalmic solution 0.06%

• Registration Number: NCT00758784
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-13
• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-25
• Primary Completion: 2009-01-14
• Study Completion: 2009-01-14
• Disposition First Submitted: 2011-09-02
• Disposition First Submitted QC: 2011-09-02
• Disposition First Posted: 2011-09-12
• Status Verified: 2020-08
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Results First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Subjects 18 years of age or older

Exclusion Criteria

• No active ocular conditions of disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bromfenac ophthalmic solution 0.06%	bromfenac ophthalmic solution 0.06%	bromfenac ophthalmic solution 0.06% bilaterally twice a day

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye	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.
Percentage of Participants With at Least One Adverse Event	52 days

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye	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.

Trial Locations

Locations (1)

ISTA Pharmaceuticals, Inc.; 🇺🇸 Irvine, California, United States