Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.

First Received: April 29, 2008 Last Updated: October 23, 2008 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00670033

Purpose

The purpose of this study is to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN and to vehicle in patients with open-angle glaucoma or ocular hypertension.

Condition	Intervention	Phase
Ocular Hypertension Open-Angle Glaucoma	Drug: Travoprost	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean IOP [ Time Frame: from baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	April 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Travoprost New Formulations	Drug: Travoprost Ophthalmic Solution
2: Active Comparator Travatan	Drug: Travoprost Ophthalmic Solution
3: Placebo Comparator Vehicle	Drug: Travoprost Ophthalmic Solution

Eligibility

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

Criteria

Inclusion Criteria:

Open-angle glaucoma
Ocular hypertension

Exclusion Criteria:

VA worse than 0.60

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670033

Locations

United States, Texas
San Antonio
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Theresa Landry )
Study ID Numbers:	C-07-46
Study First Received:	April 29, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00670033 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

IOP
Open-angle glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Travoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Travoprost
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 03, 2009