Status:
TERMINATED
Study of OT-551 Eye Drops to Prevent or Delay Progression of Nuclear Cataracts Following Vitreous Removal
Lead Sponsor:
Othera Pharmaceuticals
Conditions:
Epiretinal Membrane
Macular Hole
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00333060
Start Date
November 1 2005
End Date
January 1 2008
Last Update
April 2 2008
Active Locations (16)
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1
Peoria, Arizona, United States
2
Beverly Hills, California, United States
3
Sacramento, California, United States
4
Denver, Colorado, United States