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:

NCT00293800

First received: February 17, 2006

Last updated: February 11, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 17, 2006
Last Updated Date	February 11, 2012
Start Date ^ICMJE	July 2004
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 11, 2012)	Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline [ Time Frame: 3 months ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00293800 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 evaluate the safety and effectiveness of an investigational glaucoma therapy in 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 (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Open-Angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN) Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension Other Name: XALATAN Drug: Timolol 0.5% Ophthalmic Solution Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension Other: Timolol Vehicle Placebo
Study Arm (s)	Experimental: Travoprost/Timolol One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) each evening at 8 p.m. for 3 months Interventions: Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Other: Timolol Vehicle Active Comparator: Xalatan + Timolol 0.5% One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months Interventions: Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN) Drug: Timolol 0.5% Ophthalmic Solution
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	173
Completion Date	December 2005
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension. Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant History of chronic or recurrent severe inflammatory eye disease. History of ocular infection or ocular inflammation within the past three months in either eye. 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	NCT00293800
Other Study ID Numbers ^ICMJE	C-04-04
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	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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