Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Omeros Corporation

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).

Research Team

Eligibility Criteria

Inclusion Criteria

Competent and willing to voluntarily provide informed consent

18 years of age or older

In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia

Treatment Details

Interventions

• OMS302 (Mydriatic Agent and Anti-inflammatory Agent)

Participant Groups

Group I: OMS302 Solution Experimental Treatment 1 Intervention

OMS302 Solution

Group II: OMS302 Mydriatic Solution Experimental Treatment 1 Intervention

OMS302 Mydriatic Solution

Group III: OMS302 Anti-inflammatory Solution Experimental Treatment 1 Intervention

OMS302 Anti-inflammatory Solution

Group IV: Balanced Salt Solution (BSS) Solution Placebo Group 1 Intervention

Balanced Salt Solution (BSS) Solution

Who Is Running the Clinical Trial?

Omeros Corporation

Lead Sponsor

Trials

29

Recruited

3,800+