Back to resultsTravoprost Five Day Posology Study
Primary Purpose
Open-angle Glaucoma (OAG), Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004%
Travoprost Vehicle
Travoprost (Groups A, B and C)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma (OAG)
Eligibility Criteria
Inclusion Criteria:
- either sex and any race/ethnicity, ≥18 years old
- diagnosed with open-angle glaucoma, and/or ocular hypertension
meets the following IOP entry criteria:
- Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
- Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
- satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria:
- females of childbearing potential not meeting protocol conditions
- angle grade less than Grade 2 in either eye
- cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
- severe central visual field loss in either eye
- any abnormality preventing reliable applanation tonometry in either eye
- hypersensitivity to prostaglandin analogues or to any component of the study medication
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
TRAVATAN
Travoprost Vehicle
Travoprost Group A
Travoprost Group B
Travoprost Group C
Arm Description
TRAVATAN 0.004% once daily
Travoprost Vehicle
Travoprost Group A
Travoprost Group B
Travoprost Group C
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Secondary Outcome Measures
IOP Change From Baseline at 8 PM on Day 5
Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01114893
Brief Title
Travoprost Five Day Posology Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma (OAG), Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRAVATAN
Arm Type
Active Comparator
Arm Description
TRAVATAN 0.004% once daily
Arm Title
Travoprost Vehicle
Arm Type
Placebo Comparator
Arm Description
Travoprost Vehicle
Arm Title
Travoprost Group A
Arm Type
Experimental
Arm Description
Travoprost Group A
Arm Title
Travoprost Group B
Arm Type
Experimental
Arm Description
Travoprost Group B
Arm Title
Travoprost Group C
Arm Type
Experimental
Arm Description
Travoprost Group C
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%
Intervention Description
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Travoprost Vehicle
Intervention Description
1 drop in each eye 8 times daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Travoprost (Groups A, B and C)
Intervention Description
1 drop in each eye 8 times daily for 5 days
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
Description
Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment
Time Frame
5 days
Secondary Outcome Measure Information:
Title
IOP Change From Baseline at 8 PM on Day 5
Description
Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment
Time Frame
5 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension
meets the following IOP entry criteria:
Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent
Exclusion Criteria:
females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
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Travoprost Five Day Posology Study
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