Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal

NCT ID: NCT00333060

Last Updated: 2008-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.

Detailed Description

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Conditions

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Epiretinal Membrane Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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OT-551 ophthalmic solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Imminent vitrectomy to repair macular holes or puckers
* Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
* Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye

Exclusion Criteria

* Artificial lens or no lens in the surgical eye
* Cataract (greater than slight opacity or thickness) in the surgical eye
* Any other retinal abnormality which may be vision-threatening
* Serious heart, kidney, or liver disease
* Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
* Poorly controlled diabetes or unstable glaucoma
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Othera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Peoria, Arizona, United States

Site Status

Beverly Hills, California, United States

Site Status

Sacramento, California, United States

Site Status

Denver, Colorado, United States

Site Status

Miami, Florida, United States

Site Status

Tallahassee, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Joliet, Illinois, United States

Site Status

Baltimore, Maryland, United States

Site Status

Cherry Hill, New Jersey, United States

Site Status

Forrest Hills, New Jersey, United States

Site Status

New York, New York, United States

Site Status

Cleveland, Ohio, United States

Site Status

Bala-Cynwyd, Pennsylvania, United States

Site Status

West Chester, Pennsylvania, United States

Site Status

Abilene, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OT-551-002

Identifier Type: -

Identifier Source: org_study_id