Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omeros Corporation
• Treatments: Anti-Inflammatory Agents; Mydriatics; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Competent and willing to voluntarily provide informed consent

• 18 years of age or older

• In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia

• Other inclusion criteria to be evaluated by the investigator

Exclusion Criteria:

• No allergies to the medications and/or the active ingredients of any of the study medications

• No medications with the same activities as the 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

• Other exclusion criteria to be evaluated by the investigator