Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
1 other identifier
interventional
164
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 31, 2006
CompletedFirst Posted
Study publicly available on registry
June 2, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedApril 2, 2008
March 1, 2008
May 31, 2006
March 31, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
change in visual acuity
change in lens opacity
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Peoria, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Joliet, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Cherry Hill, New Jersey, United States
Unknown Facility
Forrest Hills, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, United States
Unknown Facility
West Chester, Pennsylvania, United States
Unknown Facility
Abilene, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 31, 2006
First Posted
June 2, 2006
Study Start
November 1, 2005
Study Completion
January 1, 2008
Last Updated
April 2, 2008
Record last verified: 2008-03