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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333060
Recruitment Status : Terminated
First Posted : June 2, 2006
Last Update Posted : April 2, 2008
Information provided by:
Othera Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Macular Hole Drug: OT-551 ophthalmic solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
Study Start Date : November 2005
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Primary Outcome Measures :
  1. change in visual acuity
  2. change in lens opacity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00333060

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United States, Arizona
Peoria, Arizona, United States
United States, California
Beverly Hills, California, United States
Sacramento, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
Tallahassee, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Joliet, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New Jersey
Cherry Hill, New Jersey, United States
Forrest Hills, New Jersey, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Bala Cynwyd, Pennsylvania, United States
West Chester, Pennsylvania, United States
United States, Texas
Abilene, Texas, United States
Sponsors and Collaborators
Othera Pharmaceuticals

Layout table for additonal information Identifier: NCT00333060    
Other Study ID Numbers: OT-551-002
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Retinal Perforations
Epiretinal Membrane
Lens Diseases
Eye Diseases
Retinal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions