A COMPARISON OF THE EFFICACY AND SAFETY OF THE DORZOLAMIDE/TIMOLOL FIXED COMBINATION GIVEN TWICE DAILY VERSUS THE LATANOPROST/TIMOLOL FIXED COMBINATION GIVEN ONCE EVERY MORNING FOLLOWING A RUN-IN PERIOD WITH TIMOLOL GIVEN ONCE DAILY - Cosopt versus Xalacom

Conditions: open-angle glaucomaocular hypertension
Classification code 10030348

Registration Number: EUCTR2005-006005-61-SI

Lead Sponsor: Pharmaceutical Research Network, LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 33

Inclusion Criteria

- adults with primary open-angle, pseudoexfoliation, or pigment dispersion glaucoma, or ocular hypertension
in both eyes
- at baseline the intraocular pressure should be 20 to 32 mm Hg inclusive at 08:00
measurement (Visit 2) after dosing with timolol the evening before
- the intraocular pressure should be 32 mm Hg or less at all time points in both eyes at
Visit 2
- visual acuity should be 6/60 or better in the study eye(s)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- any anticipated change in systemic hypotensive therapy during the trial
- use of any corticosteroids by any route for more than two weeks during the study
- contraindications to study medications

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the daytime diurnal intraocular pressure efficacy and safety of Cosopt given twice daily versus Xalacom given once every morning (with placebo in the evening) following a run-in period with Timoptol given twice daily. ;Secondary Objective: To compare the intraocular efficacy at each individual time point, every 2 hours from 08:00 to 20:00 hours.;Primary end point(s): Diurnal intraocular pressure (12 hrs)

Secondary Outcome Measures