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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00333060

Enrollment

164

Registered

2006-06-02

Start date

2005-11-30

Completion date

2008-01-31

Last updated

2008-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiretinal Membrane, Macular Hole

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.

Interventions

DRUGOT-551 ophthalmic solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change in visual acuity	—
change in lens opacity	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026