Phase 2
N=38
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT00758784 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye — -0.65 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bromfenac ophthalmic solution 0.06% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye |
-0.65 | — |
| PRIMARY Percentage of Participants With at Least One Adverse Event |
9 | — |
| SECONDARY Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye |
-0.84 | — |
Summary
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
Eligibility Criteria
Inclusion Criteria
- Subjects 18 years of age or older
Exclusion Criteria
- No active ocular conditions of disease
Data sourced from ClinicalTrials.gov (NCT00758784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.