Status:
COMPLETED
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
Lead Sponsor:
Sun Pharmaceutical Industries Limited
Conditions:
Ocular Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01190878
Start Date
August 1 2010
End Date
January 1 2011
Last Update
November 19 2021
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