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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00670033
First received: April 29, 2008
Last updated: October 23, 2008
Last verified: October 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

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
Experimental: 1
Travoprost New Formulations
 Drug: Travoprost
Ophthalmic Solution
Active Comparator: 2
Travatan
 Drug: Travoprost
Ophthalmic Solution
Placebo Comparator: 3
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: Theresa Landry, Alcon
ClinicalTrials.gov Identifier: NCT00670033     History of Changes
Other Study ID Numbers: C-07-46
Study First Received: April 29, 2008
Last Updated: October 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
IOP
Open-angle glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013