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NCT00273442 Clinical Trial

Assessing Cosopt Switch Patients

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00273442
Other study ID # PRN 05-007
Secondary ID
Status Completed
Phase Phase 4
First received January 6, 2006
Last updated November 18, 2008
Start date November 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 United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 60
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 clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension

- the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM

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

Exclusion Criteria:

- contraindications to study drugs

- anticipated change in systemic hypotensive therapy during the trial

- use of any corticosteroids by any route in the three months immediately prior to Visit 2

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• timolol maleate

• dorzolamide/timolol maleate fixed combination

Locations
Country Name City State
United States Omni Eye Services Atlanta Georgia
United States Midwest Eye Center Bourbonnais Illinois
United States Little Rock Eye Clinic Little Rock Arkansas
United States Glaucoma Consultants & Center for Eye Research Mt. Pleasant South Carolina
United States Mark J. Weiss, MD Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Pharmaceutical Research Network

Country where clinical trial is conducted

United States, 

See also
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Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
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