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NCT00465803 Clinical Trial

A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:
Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00465803
Other study ID # C-06-21
Secondary ID
Status Completed
Phase Phase 3
First received April 23, 2007
Last updated July 22, 2014
Start date March 2007

Study information
Verified date May 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients with open-angle glaucoma or ocular hypertension;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Visual acuity worse than 0.60;

- Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Travoprost 0.004%/timolol 0.5% ophthalmic solution
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid
• Travoprost ophthalmic solution, 0.004%
One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
• Timolol maleate ophthalmic solution, 0.5%
One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid

Locations
Country Name City State
United States Seattle Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient compliance Patient compliance will be measured with a dosing aid that records time and date of study drug administration 12 months No
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