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

Completed · Phase 2

Conditions studied: Cataract

In brief

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).

Key facts

Study ID

NCT01193127

Run by

Omeros Corporation

People needed

223

Starts

2010-07-01

Expected to finish

2011-02-01

Last updated by the study team

2014-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Glendale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Parker, Colorado, United States
• Study site — Largo, Florida, United States
• Study site — North Fort Myers, Florida, United States
• Study site — Panama City, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Gurnee, Illinois, United States
• Study site — Gretna, Louisiana, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Rockville Centre, New York, United States
• Study site — Bala-Cynwyd, Pennsylvania, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Nacogdoches, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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