A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT) - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2003

Last Updated Date

August 4, 2008

Start Date ^ICMJE

January 2001

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00051155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)

Official Title ^ICMJE

A 6-Week Safety and Efficacy Study of TRAVATAN Compared to XALCOM in Subjects With Open-Angle Glaucoma or Ocular Hypertension.

Brief Summary

To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Glaucoma, Open-Angle
Ocular Hypertension

Intervention ^ICMJE

Drug: Travoprost (0.004%)
Drug: Latanoprost (0.005%)/Timolol (0.5%)

Study Arms / Comparison Groups

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

Completed

Enrollment ^ICMJE

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00051155

Responsible Party

Study ID Numbers ^ICMJE

C-01-74

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Alcon Investigators

Alcon Research

Information Provided By

Alcon Research

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP