drugset / Trial / NCT00804115

The International Collaborative Exfoliation Syndrome Treatment Study

NCT00804115

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2000-08
Primary completion
2007-09
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cosopt Unknown
Comparator Latanoprost Small molecule 0.005 %
Comparator Pilocarpine Unknown 2 %
Comparator Timolol Other / unclassified 0.5 %