Back to resultsTravoprost 3-Month Safety and Efficacy Study
Primary Purpose
Open-Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution, 0.003%
Travoprost ophthalmic solution, 0.004%
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Travoprost 0.003%
TRAVATAN
Arm Description
Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Outcomes
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)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01453855
Brief Title
Travoprost 3-Month Safety and Efficacy Study
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Open-Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1099 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost 0.003%
Arm Type
Experimental
Arm Description
Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
Arm Title
TRAVATAN
Arm Type
Active Comparator
Arm Description
Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.003%
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.004%
Other Intervention Name(s)
TRAVATAN®
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
Description
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).
Time Frame
Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa A Landry, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Travoprost 3-Month Safety and Efficacy Study
We'll reach out to this number within 24 hrs