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

This study has been terminated.
Sponsor:
Information provided by:
Othera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00333060
First received: May 31, 2006
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Epiretinal Membrane
Macular Hole
Drug: OT-551 ophthalmic solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients

Resource links provided by NLM:


Further study details as provided by Othera Pharmaceuticals:

Primary Outcome Measures:
  • change in visual acuity
  • change in lens opacity

Estimated Enrollment: 164
Study Start Date: November 2005
Estimated Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333060

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00333060     History of Changes
Other Study ID Numbers: OT-551-002
Study First Received: May 31, 2006
Last Updated: March 31, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014