TerminatedPhase 2

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

United States164 participantsStarted 2005-11

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change in visual acuity

change in lens opacity

Trial details

NCT IDNCT00333060

SponsorOthera Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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