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.
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. OMS302 irrigation solution may induce and maintain an adequately dilated pupil and reduce postoperative symptoms of discomfort such as eye pain and irritation. The use of OMS302 irrigation solution may eliminate the need for pre-operative dilation of the eye and could reduce the postoperative use of an anti-inflammatory and pain medications following surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Shasta Eye Medical Group
Redding, California, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
Davis Duehr Dean
Madison, Wisconsin, United States
Pupil diameter
Time frame: Day of Surgery
Pain and other measures of ocular discomfort
Time frame: 14 days
Degree of inflammation in the anterior chamber
Time frame: 14 days
Ocular safety and changes in visual activity and intraocular pressure
Time frame: 28 days
General measures of safety
Time frame: 28 days
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