Travatan Versus Timoptic in Treating Open-Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00763061

Purpose

To evaluate the IOP lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design.The patients will receive treatment for 12 weeks.

Condition	Intervention	Phase
Glaucoma	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan) Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean IOP [ Time Frame: At the 9 AM and 4 PM time points for the patient's worse eye. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean IOP reduction [ Time Frame: Double-masked treatment phase; Week 6 examination; Week 12 examination ] [ Designated as safety issue: Yes ]

Enrollment:	112
Study Start Date:	May 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Travoprost 0.004%	Drug: Travoprost 0.004% Ophthalmic Solution (Travatan) Travoprost + Placebo at 9 AM & 9 PM
2: Active Comparator Timolol 0.5%	Drug: Timolol 0.5% Ophthalmic Solution (Timoptic) Timolol in each eye, twice daily at 9 AM & 9 PM

Eligibility

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

Criteria

Inclusion Criteria:

≥18 years;
OH or OAG with visual filed abnormality: (1)≥3 adjacent points in 24o field on the same side of the horizontal meridian,that have p <5% on the PD plot,
one of which must have p <1%(2) GHT outside normal limits(3) CPSD with p <5%;
IOP=16-30mmHg

Exclusion Criteria:

Previous damage of anterior chamber angle;
ocular inflammation or ocular surgery within the past 3 months;BCVA(logMAR)<1.0;
contact lens wearer;
severe central field loss;
uncontrolled cardiovascular, hepatic or renal disease;
any medication within past 1M.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763061

Locations

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

Responsible Party:	Alcon Research Ltd ( Benny Li, Ph.D. )
Study ID Numbers:	MS-06-02
Study First Received:	September 26, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00763061
Health Authority:	Hong Kong: Department of Health

Keywords provided by Alcon Research:

Glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Timolol

Cloprostenol
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Reproductive Control Agents
Cardiovascular Agents

Antihypertensive Agents
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 14, 2009