Status:
COMPLETED
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Lead Sponsor:
Omeros Corporation
Conditions:
Intraocular Lens Replacement
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surge...
Eligibility Criteria
Inclusion
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia
Exclusion
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT01454063
Start Date
September 1 2011
End Date
March 1 2012
Last Update
August 21 2014
Active Locations (16)
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1
Chandler, Arizona, United States, 85224
2
Glendale, Arizona, United States, 85308
3
Los Angeles, California, United States, 90013
4
Cape Coral, Florida, United States, 33904