Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
Phase 2
Terminated
- Conditions
- Epiretinal MembraneMacular Hole
- Registration Number
- NCT00333060
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 164
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in visual acuity change in lens opacity
- Secondary Outcome Measures
Name Time Method