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

• Sponsor: Othera Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00333060
• Collaborator: (none)
• Enrollment: 164
• Locations: 16
• Duration (Months): 26
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane; Macular Hole	Drug: OT-551 ophthalmic solution	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
• Study Start Date: Nov 1, 2005
• Anticipated Study Completion Date: Jan 1, 2008

Outcome Measures

Primary Outcome Measures

1. change in visual acuity []

2. change in lens opacity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Peoria	Arizona	United States
2		Beverly Hills	California	United States
3		Sacramento	California	United States
4		Denver	Colorado	United States
5		Miami	Florida	United States
6		Tallahassee	Florida	United States
7		Chicago	Illinois	United States
8		Joliet	Illinois	United States
9		Baltimore	Maryland	United States
10		Cherry Hill	New Jersey	United States
11		Forrest Hills	New Jersey	United States
12		New York	New York	United States
13		Cleveland	Ohio	United States
14		Bala Cynwyd	Pennsylvania	United States
15		West Chester	Pennsylvania	United States
16		Abilene	Texas	United States

Sponsors and Collaborators

• Othera Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00333060
• Other Study ID Numbers: OT-551-002
• First Posted: Jun 2, 2006
• Last Update Posted: Apr 2, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Cataract; Retinal Perforations; Epiretinal Membrane; Ophthalmic Solutions

Study Results

No Results Posted as of Apr 2, 2008