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

March 31, 2008 updated by: Othera Pharmaceuticals

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Sacramento, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Tallahassee, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
      • Joliet, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Forrest Hills, New Jersey, United States
    • New York
      • New York, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States
      • West Chester, Pennsylvania, United States
    • Texas
      • Abilene, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in visual acuity
change in lens opacity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Othera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (ANTICIPATED)

January 1, 2008

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

May 31, 2006

First Posted (ESTIMATE)

June 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT-551-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe