Phase 2
Completed N=169
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
Ocular Inflammation
Source: ClinicalTrials.gov NCT01190878 ↗
Enrolled (actual)
169
Serious AEs
1.2%
Results posted
Jul 2016
Primary outcomePrimary: Ocular Inflammation — 21; 24; 18; 8 participants
Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Inflammation |
21; 24; 18; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment
- Meet the best corrected visual acuity score requirement
- Meet the IOP requirement
- Additional inclusion criteria also apply
Exclusion Criteria
- Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications
- Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery
- Additional exclusion criteria also apply
Data sourced from ClinicalTrials.gov (NCT01190878). 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.