open-angle glaucoma ocular hypertension Classification code 10030348
Conditions
Interventions
Trade Name: Cosopt
Product Name: Cosopt
Product Code: not applicable
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: dorzolamide
Concentration unit: % percent
Concentration type: equal
C
Sponsors
Pharmaceutical Research Network, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Slovenia
Outcome results
None listed