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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00311389

First received: April 4, 2006

Last updated: February 11, 2012

Last verified: February 2012

History of Changes

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Latanoprost Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean Intraocular Pressure (IOP) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	408
Study Start Date:	January 2003
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

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

Criteria

Inclusion Criteria:

- As specified in protocol

Exclusion Criteria:

- As specified in protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311389

Locations

Belgium
European Facilitiies
Puurs, Belgium

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00311389 History of Changes
Other Study ID Numbers:	C-02-28
Study First Received:	April 4, 2006
Last Updated:	February 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Glaucoma
POAG
OAG
OHT

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Travoprost
Maleic acid
Adrenergic beta-Antagonists

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

To Top