Safety and Efficacy of Changing to Duo-Travatan in Patients Uncontrolled on Timolol

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01336569

First received: April 14, 2011

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 14, 2011
Last Updated Date	June 7, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 14, 2011)	Mean IOP Change at the final visit from baseline from prior beta-blocker monotherapy. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01336569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Changing to Duo-Travatan in Patients Uncontrolled on Timolol
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study to assess the safety and IOP-lowering efficacy of changing to Duo-Travatan from prior Timolol 0.5% monotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Drug: Travoprost/Timolol Maleate Fixed Combination Patients switch from prior therapy to Travoprost/Timolol administered once daily for up to 6 weeks
Study Arm (s)	DuoTrav Single arm study. Transition to Duo-Travatan from prior therapy (historical control) Intervention: Drug: Travoprost/Timolol Maleate Fixed Combination
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	51
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of ocular hypertension Primary open-angle or pigment dispersion glaucoma in both eyes IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye) Wiliness to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any component of Duo-Travatan® that is deemed clinically significant in the opinion of the Principal Investigator Corneal dystrophies in either eye Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment Bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker History of severe allergic rhinitis A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject Participation in any other investigational study within 30 days prior to the Screening Visit
Gender	Both
Ages	18 Years and older
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 Number ^ICMJE	NCT01336569
Other Study ID Numbers ^ICMJE	SMA-09-26
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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