Back to resultsTravoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension, Open-angle Glaucoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution (new formulation)
Travoprost ophthalmic solution, 0.004%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension focused on measuring IOP, Open-angle glaucoma, Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Satisfy all informed consent requirements;
- Diagnosed with open-angle glaucoma or ocular hypertension;
- Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
- IOP measurements in at least 1 eye as specified in protocol;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
- Any form of glaucoma other than open-angle glaucoma;
- Severe central visual field loss in either eye;
- Chronic, recurrent or severe inflammatory eye disease;
- Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
- Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
- Intraocular surgery within the past 6 months;
- Ocular laser surgery within the past 3 months;
- Any abnormality preventing reliable applanation tonometry;
- Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Travoprost new formulation
TRAVATAN
Vehicle
Arm Description
Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Outcomes
Primary Outcome Measures
Mean change from baseline in intraocular pressure (IOP)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Secondary Outcome Measures
Mean intraocular pressure
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Mean percent change from baseline in IOP
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00670033
Brief Title
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title
Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open-angle Glaucoma
Keywords
IOP, Open-angle glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Travoprost new formulation
Arm Type
Experimental
Arm Description
Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Arm Title
TRAVATAN
Arm Type
Active Comparator
Arm Description
Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution (new formulation)
Intervention Type
Drug
Intervention Name(s)
Travoprost ophthalmic solution, 0.004%
Other Intervention Name(s)
TRAVATAN®, TRAVATAN Z®
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Inactive ingredients used as a placebo
Primary Outcome Measure Information:
Title
Mean change from baseline in intraocular pressure (IOP)
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Time Frame
Baseline, Up to Week 4
Secondary Outcome Measure Information:
Title
Mean intraocular pressure
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
Baseline, Up to Week 4
Title
Mean percent change from baseline in IOP
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.
Time Frame
Baseline, Up to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Satisfy all informed consent requirements;
Diagnosed with open-angle glaucoma or ocular hypertension;
Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit;
IOP measurements in at least 1 eye as specified in protocol;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures;
Any form of glaucoma other than open-angle glaucoma;
Severe central visual field loss in either eye;
Chronic, recurrent or severe inflammatory eye disease;
Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator;
Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR);
Intraocular surgery within the past 6 months;
Ocular laser surgery within the past 3 months;
Any abnormality preventing reliable applanation tonometry;
Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Landry, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension
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