A Long-term Safety Study of Once-daily Travatan - Full Text View

Sponsor:	Alcon Research
Information provided by (Responsible Party):	Alcon Research
ClinicalTrials.gov Identifier:	NCT00051168

Purpose

Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Glaucoma, Open-angle Ocular Hypertension	Drug: Travatan	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-term Safety Study of Once-daily TRAVATAN

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean Intraocular Pressure [ Time Frame: At 5 years. ] [ Designated as safety issue: Yes ]
Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.

All IOP measurements were performed with a Goldmann applanation tonometer.

Enrollment:	502
Study Start Date:	January 2006
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Travatan Travoprost (0.004%)	Drug: Travatan Travoprost (0.004%) 1 drop each eye once daily

Eligibility

Criteria

Adult patients of any race and either sex with chronic angle-closure glaucoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051168

Locations

United States, Texas
Europe
Fort Worth, Texas, United States

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00051168 History of Changes
Other Study ID Numbers:	C-02-20
Study First Received:	January 3, 2003
Results First Received:	March 22, 2010
Last Updated:	October 2, 2011
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
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 13, 2012