Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Ph… (NCT00721695) | Clinical Trial Compass
CompletedPhase 1/2
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.
United States60 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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 …