Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial phacoemulsification process.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omeros Corporation
• Treatments: Mydriatics; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subject is 50 years of age or older.

• Subject is to undergo unilateral primary CELR for an age-related cataract under topical anesthesia and using a clear cornea incision.

• Subject's history and physical examination are within normal limits or the examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.

• Subject has best corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.

• Subject has intraocular pressure (IOP) between 5 mmHg and 22 mmHg, inclusive, in the study eye.

Exclusion Criteria:

• Subject is allergic to any of the individual ingredients in OMS302

• Subject who is taking medications with the same activities as that of the active ingredients in OMS302 for defined time intervals prior to and after surgery.

• Female subject of childbearing potential (i.e., not surgically sterilized nor post-menopausal longer than one year) who is not using an effective method of birth control within at least 14 days prior to surgery or has a positive pregnancy test.

• Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory, or medical disorder as determined by the Investigator.

• Subject who is taking anticoagulants.

• Subject who is taking or needs to take for the duration of the study any of the prohibited medications.

• Subject with pseudo-capsular exfoliation, or evidence of prior iritis or of ocular trauma with iris damage, or who has used pilocarpine within six months of screening.

• Subject that has uncontrolled chronic ocular disease.

• Subject that has active corneal pathology or scarring noted in either eye (except superficial punctate keratopathy in the non-study eye).

• Subject that has extraocular/intraocular inflammation in either eye.

• Subject has an active bacterial and/or viral infection in either eye.

• Subject that has narrow-angle glaucoma, unstable glaucoma, or glaucoma being treated with prostaglandins or prostaglandin analogues.

• Subject taking, or has taken within the past year, an alpha adrenergic antagonist.

• Subject that has participated in or is currently participating in any investigational drug or device trial within the previous 30 days prior to the day of surgery.

• Subject that has had intraocular conventional surgery within the past three months or intraocular laser surgery within one month of the planned surgery in the study eye.

• Subject that requires the use of other topical medications during the trial except prophylactic antibiotics, topical lid care or glaucoma medications or tear replacement solutions.

• Subject that needs other ocular surgery at the time of the cataract extraction.