Phase IV Study of TRAVATAN 0.004% in Subjects With Iris Pigmentation Changes

This study is ongoing, but not recruiting participants.

First Received on October 8, 2002. Last Updated on November 4, 2011 History of Changes

Sponsor:	Alcon Research
Information provided by (Responsible Party):	Alcon Research
ClinicalTrials.gov Identifier:	NCT00047554

Purpose

To monitor iris pigmentation changes over a five year period in subjects with open-angle glaucoma or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN.

Condition	Intervention	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: Travatan 0.004%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase IV Safety Study of TRAVATAN 0.004% in Subjects With TRAVATAN Induced Iris Pigmentation Changes C-01-79.

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:

Iris photography [ Time Frame: Every 6 months for first 2 years, then yearly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Travatan 0.004% Travatan 0.004% Opthalmic Suspension 1 drop QD	Drug: Travatan 0.004% Travatan 0.004% 1 drop QD

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Subjects of any race and of either sex diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension who have experienced an iris pigmentation change while dosing with TRAVATAN and who are currently using TRAVATAN

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047554

Locations

United States, Texas
Alcon Call Center For Locations
Multiple Cities & Multiple States, Texas, United States

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00047554 History of Changes
Other Study ID Numbers:	C-01-79, C-01-79
Study First Received:	October 8, 2002
Last Updated:	November 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

open-angle
glaucoma
ocular
hypertension

POAG
Iris
Pigmentation

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 09, 2012