Travoprost Five Day Posology Study

Study Overview
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Brief Summary
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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.

Conditions
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Open-angle Glaucoma (OAG), Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost 0.004%
* Drug: Travoprost Vehicle
* Drug: Travoprost (Groups A, B and C)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TRAVATAN<br>TRAVATAN 0.004% once daily | Drug: Travoprost 0.004%<br>* 1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days<br>|
| Placebo Comparator: Travoprost Vehicle<br>Travoprost Vehicle | Drug: Travoprost Vehicle<br>* 1 drop in each eye 8 times daily for 5 days<br>|
| Experimental: Travoprost Group A<br>Travoprost Group A | Drug: Travoprost (Groups A, B and C)<br>* 1 drop in each eye 8 times daily for 5 days<br>|
| Experimental: Travoprost Group B<br>Travoprost Group B | Drug: Travoprost (Groups A, B and C)<br>* 1 drop in each eye 8 times daily for 5 days<br>|
| Experimental: Travoprost Group C<br>Travoprost Group C | Drug: Travoprost (Groups A, B and C)<br>* 1 drop in each eye 8 times daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 Days |