Dry Eye Study With Cosopt® Over 8 Weeks in Patients With Open-Angle Glaucoma or Ocular Hypertension (0507A-152)(COMPLETED)

Phase 4 Completed 176 enrolled Merck Sharp & Dohme LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

To evaluate if preservative free cosopt is well tolerated in patients with Open angle glaucoma (OAG) or Ocular hypertension (OH) with dry eyes.

Timeline

Start: 2007-05-23
Primary completion: 2008-09-15
Completion: 2008-09-15

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Preservative-free Dorzolamide-timolol (COSOPT®) Week 8; p = 0.097; Mean Difference (Net) 3.2 (95% CI -0.6 to 7.0); t-test, 2 sided NCT00545064 ↗

paper The mean (SD) GSS-SYMP-6 score increased from 73.6 (21.8) at baseline to 76.1 (20.7) at 8 weeks (P = 0.097). PMID 20668720 ↗

Publications

Results Hutnik C, Neima D, Ibrahim F, Scott R, Vaillancourt J, Haine D, Sampalis JS, Bastien N, Foucart S. Tolerability and effectiveness of preservative-free dorzolamide-timolol (preservative-free COSOPT) in patients with open-angle glaucoma or ocular hypertension. Clin Ophthalmol. 2010 Jul 21;4:581-90. doi: 10.2147/opth.s10337.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dorzolamide	Small molecule	2 %	—
Subject	Timolol	Other / unclassified	0.5 %	—