CompletedNCT00273481Updated Nov 19, 2008

Cosopt Versus Xalacom

A Phase 4 interventional study of dorzolamide 2%/timolol maleate 0.5% fixed combination and latanoprost 0.005%/timolol maleate 0.5% fixed combination in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Pharmaceutical Research Network. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-11-19.

Sponsored by Pharmaceutical Research Network · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 33
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Open-Angle Glaucoma
Ocular Hypertension

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In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 33 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

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Lead sponsor

Pharmaceutical Research Network is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double
Enrollment: 33 participants

Interventions

Drugdorzolamide 2%/timolol maleate 0.5% fixed combination
Druglatanoprost 0.005%/timolol maleate 0.5% fixed combination
Drugtimolol maleate 0.5%
Drugplacebo

Study locations

2 sites

Lawson Health Research Insitute
London, Ontario N6A 4G5, Canada
University Eye Clinic
Ljubljana, A525, Slovenia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00273481
Lead sponsor: Pharmaceutical Research Network
First posted: Jan 9, 2006
Start date: Sep 2005
Completion: Apr 2007
Last update: Nov 19, 2008

Study contacts

William C. Stewart, MD

study director · Pharmaceutical Research Network, LLC

Cindy M. Hutnik, BSc, PhD, MD

principal investigator · London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Barbara Cvenkel, MD

principal investigator · University Eye Clinic Ljubljana

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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