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

NCT01193127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2014-08-28

Study results available
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Summary

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).

Conditions

  • Cataract

Interventions

DRUG

OMS302 Solution

DRUG

OMS302 Mydriatic Solution

DRUG

OMS302 Anti-inflammatory Solution

DRUG

Balanced Salt Solution (BSS) Solution

Sponsors & Collaborators

  • Omeros Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-01-31
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193127 on ClinicalTrials.gov