Cosopt Versus Xalacom

Pharmaceutical Research Network

Status and phase

Completed

Phase 4

Conditions

Open-Angle Glaucoma

Ocular Hypertension

Treatments

Drug: dorzolamide 2%/timolol maleate 0.5% fixed combination

Drug: placebo

Drug: timolol maleate 0.5%

Drug: latanoprost 0.005%/timolol maleate 0.5% fixed combination

Study type

Interventional

Funder types

Other

Identifiers

NCT00273481

PRN 05-001

Details and patient eligibility

About

To compare the intraocular pressure efficacy and safety of the DTFC given twice daily versus the LTFC given once every morning following a run-in period with timolol maleate given twice daily.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adults with primary open-angle or pigment-dispersion glaucoma, or ocular hypertension
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 the time points in both eyes at Visit 2
visual acuity should be 6/60 or better in the study eye(s)

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 medicines