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Travoprost 3-Month Safety and Efficacy Study

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ClinicalTrials.gov Identifier: NCT01453855
Recruitment Status : Completed
First Posted : October 18, 2011
Results First Posted : October 18, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Travoprost ophthalmic solution, 0.003% Drug: Travoprost ophthalmic solution, 0.004% Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost
U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453855


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01453855     History of Changes
Other Study ID Numbers: C-11-034
2011-004587-29 ( EudraCT Number )
First Posted: October 18, 2011    Key Record Dates
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Travoprost
Antihypertensive Agents