Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

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

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: bromfenac ophthalmic solution 0.06%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years of age or older Exclusion Criteria: No active ocular conditions of disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bromfenac ophthalmic solution 0.06%<br>bromfenac ophthalmic solution 0.06% bilaterally twice a day | Drug: bromfenac ophthalmic solution 0.06%<br>* bromfenac ophthalmic solution 0.06% bilaterally twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye | 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. | Baseline, Day 42 | 
| Percentage of Participants With at Least One Adverse Event |  | 52 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye | 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. | Baseline, 42 days |