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The International Collaborative Exfoliation Syndrome Treatment Study

NCT00804115 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2008-12-08

No results posted yet for this study

Summary

Purpose: To determine the efficacy of treatment with latanoprost in combination with pilocarpine versus timolol or timolol/dorzolamide fixed combination (Timoptic or Cosopt) in eyes with XFS and elevated intraocular pressure (IOP).

Methods: This is a randomized, open-label study to test the hypothesis that improving both pressure-dependent and pressure-independent aqueous outflow and minimizing iridolenticular friction will interfere with the progression of XFS, allow improvement in trabecular function, and be more effective over time than simply reducing aqueous formation. Randomization was performed across the centers, per patient rather than per eye to avoid any crossover effect caused by aqueous suppressants. Group I was treated with latanoprost and pilocarpine, both in the evening, and Group II with Timolol or Cosopt b.i.d. Only one eye per patient was randomized. Patients were followed for 2 years with assessment of IOP, visual field progression, tonographic outflow coefficient and trabecular pigmentation at the 6:00 and 12:00 position.

Conditions

Interventions

DRUG

Latanoprost with Pilocarpine vs Timolol or Cosopt

Timolol 0.5% bid or Cosopt bid Latanoprost 0.005% qhs Pilocarpine 2%

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • The New York Eye & Ear Infirmary

    lead OTHER

Principal Investigators

  • Robert Ritch, MD · New York Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2007-09-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804115 on ClinicalTrials.gov