Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- bromfenac ophthalmic solution 0.06%
- Conditions
- Dry Eye Disease
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects 18 years of age or older
Exclusion Criteria
- •No active ocular conditions of disease
Arms & Interventions
bromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Intervention: bromfenac ophthalmic solution 0.06%
Outcomes
Primary Outcomes
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.
Percentage of Participants With at Least One Adverse Event
Time Frame: 52 days
Secondary Outcomes
- Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye(Baseline, 42 days)