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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00273429
Other study ID # PRN 04-015
Secondary ID
Status Completed
Phase Phase 4
First received January 6, 2006
Last updated January 8, 2007
Start date April 2005
Est. completion date December 2005

Study information

Verified date January 2007
Source Pharmaceutical Research Network
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion

- intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H

- ETDRS visual acuity must be 1.0 or better in both eyes

Exclusion Criteria:

- any contraindications to study medications

- any anticipated change in systemic hypertensive therapy during the trial

Study Design

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


Intervention

Drug:
timolol maleate 0.5%

dorzolamide/timolol maleate fixed combination

latanoprost 0.005%

placebo


Locations

Country Name City State
United States Midwest Eye Center SC Bourbonnais Illinois
United States Central Florida Eye Associates Lakeland Florida

Sponsors (1)

Lead Sponsor Collaborator
Pharmaceutical Research Network

Country where clinical trial is conducted

United States, 

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