Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

This study has been terminated.

( Management decision not to conduct an additional efficacy study. )

First Received: March 16, 2009 Last Updated: June 2, 2009 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00862472

Purpose

The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: DuoTrav APS Drug: DuoTrav	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean Intraocular Pressure (IOP) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	330
Study Start Date:	April 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DuoTrav APS: Experimental DuoTrav APS QD AM	Drug: DuoTrav APS DuoTrav APS QD AM
DuoTrav: Active Comparator DuoTrav QD AM	Drug: DuoTrav DuoTrav QD AM

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

VA not worse than 0.60
additional clinically relevant ocular or systemic conditions may be excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862472

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon, Glaucoma Clinical Science ( Jennifer Thomas, Ph.D./Sr. Clinical Study Manager )
Study ID Numbers:	C-09-006
Study First Received:	March 16, 2009
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00862472 History of Changes
Health Authority:	United States: Food and Drug Administration; New Zealand: The Standing Committee on Therapeutic Trials and Multi-Region Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; Taiwan: Institutional Review Board; Taiwan: Department of Health

Keywords provided by Alcon Research:

open-angle glaucoma
ocular hypertension
open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle

Vascular Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Cardiovascular Diseases
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009