Travoprost 3-Month Safety and Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01453855
First received: October 13, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]
    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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453855

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01453855     History of Changes
Other Study ID Numbers: C-11-034, 2011-004587-29
Study First Received: October 13, 2011
Results First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014