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

NCT ID: NCT01193127

Last Updated: 2014-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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OMS302 Solution

OMS302 Solution

Group Type EXPERIMENTAL

OMS302 Solution

Intervention Type DRUG

OMS302 Mydriatic Solution

OMS302 Mydriatic Solution

Group Type EXPERIMENTAL

OMS302 Mydriatic Solution

Intervention Type DRUG

OMS302 Anti-inflammatory Solution

OMS302 Anti-inflammatory Solution

Group Type EXPERIMENTAL

OMS302 Anti-inflammatory Solution

Intervention Type DRUG

Balanced Salt Solution (BSS) Solution

Balanced Salt Solution (BSS) Solution

Group Type PLACEBO_COMPARATOR

Balanced Salt Solution (BSS) Solution

Intervention Type DRUG

Interventions

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OMS302 Solution

Intervention Type DRUG

OMS302 Mydriatic Solution

Intervention Type DRUG

OMS302 Anti-inflammatory Solution

Intervention Type DRUG

Balanced Salt Solution (BSS) Solution

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* No allergies to the medications and/or the active ingredients of any of the study medications
* No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
* No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omeros Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chandler, Arizona, United States

Site Status

Glendale, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Los Angeles, California, United States

Site Status

Parker, Colorado, United States

Site Status

Largo, Florida, United States

Site Status

North Fort Myers, Florida, United States

Site Status

Panama City, Florida, United States

Site Status

Tamarac, Florida, United States

Site Status

Gurnee, Illinois, United States

Site Status

Gretna, Louisiana, United States

Site Status

Kansas City, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Omaha, Nebraska, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Rockville Centre, New York, United States

Site Status

Bala-Cynwyd, Pennsylvania, United States

Site Status

Goodlettsville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Nacogdoches, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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C09-001

Identifier Type: -

Identifier Source: org_study_id

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