Trial | NCT00333060  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    ot-551 ...

  • Study Participants

    164
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.
Study Started
Nov 30
2005
Study Completion
Jan 31
2008
Anticipated
Last Update
Apr 02
2008
Estimate

Drug OT-551 ophthalmic solution

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
No Results Posted