Travoprost Five Day Posology Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedResults Posted
Study results publicly available
June 23, 2011
CompletedJune 23, 2011
May 1, 2011
1 month
April 30, 2010
May 26, 2011
May 26, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
5 days
Secondary Outcomes (1)
IOP Change From Baseline at 8 PM on Day 5
5 Days
Study Arms (5)
TRAVATAN
ACTIVE COMPARATORTRAVATAN 0.004% once daily
Travoprost Vehicle
PLACEBO COMPARATORTravoprost Vehicle
Travoprost Group A
EXPERIMENTALTravoprost Group A
Travoprost Group B
EXPERIMENTALTravoprost Group B
Travoprost Group C
EXPERIMENTALTravoprost Group C
Interventions
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
1 drop in each eye 8 times daily for 5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Research, Lt.d
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2010
First Posted
May 3, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2010
Last Updated
June 23, 2011
Results First Posted
June 23, 2011
Record last verified: 2011-05