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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00465803
First received: April 23, 2007
Last updated: July 22, 2014
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution
Drug: Travoprost ophthalmic solution, 0.004%
Drug: Timolol maleate ophthalmic solution, 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Patient compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient compliance will be measured with a dosing aid that records time and date of study drug administration


Enrollment: 81
Study Start Date: March 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DuoTrav
One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid
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
Other Name: DuoTrav
Travatan/Timolol
One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.
Drug: Travoprost ophthalmic solution, 0.004%
One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid
Other Name: TRAVATAN
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465803

Locations
United States, Washington
Seattle
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00465803     History of Changes
Other Study ID Numbers: C-06-21
Study First Received: April 23, 2007
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Open-angle glaucoma or ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Cloprostenol
Ophthalmic Solutions
Pharmaceutical Solutions
Timolol
Travoprost
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014