A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00293761

First received: February 17, 2006

Last updated: March 2, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 17, 2006
Last Updated Date	March 2, 2012
Start Date ^ICMJE	January 2006
Primary Completion Date	May 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 20, 2007)	Mean IOP
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00293761 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	A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Open-angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Travoprost, Investigational One drop in study eye once daily for 13 days Drug: Travoprost (TRAVATAN) One drop in study eye once daily for 13 days Other Name: TRAVATAN
Study Arm (s)	Experimental: Travatan, Investigational Intervention: Drug: Travoprost, Investigational Active Comparator: Travatan Intervention: Drug: Travoprost (TRAVATAN)
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	109
Completion Date	May 2006
Primary Completion Date	May 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under age 18. 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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00293761
Other Study ID Numbers ^ICMJE	C-05-51
Has Data Monitoring Committee	Not Provided
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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