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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00273455
Other study ID # PRN 05-017
Secondary ID
Status Completed
Phase Phase 4
First received January 6, 2006
Last updated November 18, 2008
Start date January 2006
Est. completion date May 2007

Study information

Verified date November 2008
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 intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes

- on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement

- visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

- historical failure to respond to topical beta-blockers in a clinically meaningful manner

- any contraindication to study medications

- any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
bimatoprost 0.03%

dorzolamide 2%/timolol maleate 0.5% fixed combination

placebo


Locations

Country Name City State
United States Houston Eye Associates Houston Texas
United States Taustine Eye Center Louisville Kentucky
United States Glaucoma Consultants & Center for Eye Research, PA Mt. Pleasant South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Pharmaceutical Research Network

Country where clinical trial is conducted

United States, 

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