NCT00721695

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

Randomized, Controlled, Double-Masked, Multicenter, Exploratory Study of the Clinical Benefit and Safety of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) Using a Coaxial Phacoemulsification Process

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Omeros Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Cataract Extraction

Interventions

Type	Name	Description
DRUG	OMS302	OMS302 Irrigation Solution
DRUG	OMS302-PE	OMS302-PE HCI Irrigation Solution
DRUG	Vehicle	Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-07-24
• Last updated: 2014-07-18

Locations

4 sites across 1 country: United States