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Travoprost 3-Month Safety and Efficacy Study

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: October 13, 2011
Last updated: August 13, 2013
Last verified: August 2013
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost ophthalmic solution, 0.003% Drug: Travoprost ophthalmic solution, 0.004% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) [ Time Frame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM) ]
    As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Enrollment: 1099
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost 0.003%
Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
Drug: Travoprost ophthalmic solution, 0.003%
Active Comparator: TRAVATAN
Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Drug: Travoprost ophthalmic solution, 0.004%
Other Name: TRAVATAN®

Detailed Description:
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
  • Qualifying intraocular pressure at both eligibility visits.
  • Understand and sign an informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
  • Severe central visual field loss in either eye.
  • Chronic, recurrent or severe inflammatory eye disease.
  • Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
  • Any abnormality preventing reliable applanation tonometry.
  • Hypersensitivity to prostaglandin analogs or to any component of the study medications.
  • Therapy with another investigational agent within 30 days prior to the Screening Visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01453855

Sponsors and Collaborators
Alcon Research
Study Director: Theresa A Landry, PhD Alcon Research
  More Information

Responsible Party: Alcon Research Identifier: NCT01453855     History of Changes
Other Study ID Numbers: C-11-034
2011-004587-29 ( EudraCT Number )
Study First Received: October 13, 2011
Results First Received: August 13, 2013
Last Updated: August 13, 2013

Keywords provided by Alcon Research:
Open-Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents processed this record on September 21, 2017