Status:
COMPLETED
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.
Lead Sponsor:
Omeros Corporation
Conditions:
Cataract Extraction
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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 phacoemulsificatio...
Detailed Description
OMS302 Injection is a mydriatic/anti-inflammatory combination investigational drug product being developed as an irrigation solution during intracameral lens replacement surgical procedures of the eye...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00721695
Start Date
May 1 2008
End Date
February 1 2009
Last Update
July 18 2014
Active Locations (4)
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1
Shasta Eye Medical Group
Redding, California, United States, 96002
2
Chu Vision Institute
Bloomington, Minnesota, United States, 55420
3
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
4
Davis Duehr Dean
Madison, Wisconsin, United States, 53715