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

Epiretinal Membrane Clinical Trial

Official title:

Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00333060
• Other study ID #: OT-551-002
• Status: Terminated
• Phase: Phase 2
• First received: May 31, 2006
• Last updated: March 31, 2008
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: March 2008
• Source: Othera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 164
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Hole

Intervention

Drug:
• OT-551 ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Othera Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in visual acuity
Primary	change in lens opacity