Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00928590

First received: June 24, 2009

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 24, 2009
Last Updated Date	May 16, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2009)	Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00928590 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 Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title ^ICMJE	A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary	The purpose of the study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Open-angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Travoprost/Timolol Maleate Fixed Combination (POLYQUAD-preserved) solution (DuoTrav APS) One drop in the study eye(s) once daily, at 9 AM, for 12 months Other Name: DuoTrav APS
Study Arm (s)	Experimental: DuoTrav APS One drop in the study eye(s) once daily, at 9 AM, for 12 months Intervention: Drug: Travoprost/Timolol Maleate Fixed Combination (POLYQUAD-preserved) solution (DuoTrav APS)
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	155
Completion Date	Not Provided
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication in the opinion of the investigator. Patients who are currently on a stable treatment of IOP-lowering medication. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: BCVA not worse than 55 letters Additional clinically relevant ocular or systemic conditions may be excluded. Other protocol-defined exclusion criteria may apply.
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	NCT00928590
Other Study ID Numbers ^ICMJE	C-09-032, EudraCT Number 2009-013178-42
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	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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