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

Tracking Information
First Received Date ^ICMJE	October 8, 2002
Last Updated Date	June 11, 2009
Start Date ^ICMJE	March 2007
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2009)	Iris photography [ Time Frame: Every 6 months for first 2 years, then yearly ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00047554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase IV Study of TRAVATAN 0.004% in Subjects With Iris Pigmentation Changes
Official Title ^ICMJE	A Phase IV Safety Study of TRAVATAN 0.004% in Subjects With TRAVATAN Induced Iris Pigmentation Changes C-01-79.
Brief Summary	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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Open-Angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Travatan 0.004%
Study Arms / Comparison Groups	Experimental: Travatan 0.004% Opthalmic Suspension 1 drop QD
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	250
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047554
Responsible Party	Jaime Dickerson, Alcon
Study ID Numbers ^ICMJE	C-01-79, C-01-79
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Alcon Research
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP