Phase 3
Completed N=420
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Source: ClinicalTrials.gov NCT01212471 ↗Enrolled (actual)
420
Serious AEs
1.4%
Results posted
Sep 2020
Primary outcomePrimary: Mean Ocular Surface Disease Index (OSDI) Total Score — 35.0; 40.3; 36.9 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Surface Disease Index (OSDI) Total Score |
35.0; 40.3; 36.9 | — |
Eligibility Criteria
Inclusion Criteria
- Be of either gender and any race 18 years or older
Exclusion Criteria
- Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study
Data sourced from ClinicalTrials.gov (NCT01212471). 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. Informational only — not medical advice.