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NCT00273481 Clinical Trial

Cosopt Versus Xalacom

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00273481
Other study ID # PRN 05-001
Secondary ID
Status Completed
Phase Phase 4
First received January 6, 2006
Last updated November 18, 2008
Start date September 2005
Est. completion date April 2007

Study information
Verified date November 2008
Source Pharmaceutical Research Network
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

• latanoprost 0.005%/timolol maleate 0.5% fixed combination

• timolol maleate 0.5%

• placebo

Locations
Country Name City State
Canada Lawson Health Research Insitute London Ontario
Slovenia University Eye Clinic Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
Pharmaceutical Research Network

Countries where clinical trial is conducted

Canada,  Slovenia, 

See also
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