Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

Completed · Phase 3 · Has a placebo group

Conditions studied: Intraocular Lens Replacement

In brief

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Key facts

Study ID

NCT01579565

Run by

Omeros Corporation

People needed

416

Starts

2012-04-01

Expected to finish

2013-01-01

Last updated by the study team

2017-06-14

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 or lens extraction with lens replacement surgery in one eye, under topical anesthesia

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 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Washington, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Zwolle, Netherlands

Full record on ClinicalTrials.gov

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