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A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00311389
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-angle Ocular Hypertension Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : January 2003
Primary Completion Date : September 2004
Study Completion Date : September 2004


Arms and Interventions

Arm Intervention/treatment
Experimental: Travoprost/Timolol
1 drop in the affected eye(s) once daily in the morning for 12 months
Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Active Comparator: Latanoprost/Timolol
1 drop in the affected eye(s) once daily in the morning for 12 months
Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension


Outcome Measures

Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- As specified in protocol

Exclusion Criteria:

- As specified in protocol

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311389


Locations
Belgium
European Facilitiies
Puurs, Belgium
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00311389     History of Changes
Other Study ID Numbers: C-02-28
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Glaucoma
POAG
OAG
OHT

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Latanoprost
Travoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents