Divided Dose of TRAVATAN®

Study Overview
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Brief Summary
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The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost Ophthalmic Solution, 0.00013%
* Drug: Travoprost Ophthalmic Solution, 0.00033%
* Drug: Travoprost Ophthalmic Solution, 0.001%
* Drug: Travoprost Ophthalmic Solution, 0.00267%
* Drug: Travoprost Ophthalmic Solution, 0.004%
* Drug: Travoprost Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria: Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1; Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1. Must sign an informed consent form. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures. Current or history of ocular inflammation or infection in either eye within the past 3 months. Corneal thickness greater than 620 µm as determined by pachymetry in either eye. Severe visual field loss. Cup to disc ratio greater than 0.8 in either eye. Intraocular surgery within the past 6 months in either eye. Other protocol-defined exclusion criteria may apply.

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 |
| --- | --- |
| Experimental: Trav 0.00013%<br>Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days | Drug: Travoprost Ophthalmic Solution, 0.00013%<br>* Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose<br>|
| Experimental: Trav 0.00033%<br>Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days | Drug: Travoprost Ophthalmic Solution, 0.00033%<br>* Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose<br>|
| Experimental: Trav 0.001%<br>Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days | Drug: Travoprost Ophthalmic Solution, 0.001%<br>* Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose<br>|
| Experimental: Trav 0.00267%<br>Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days | Drug: Travoprost Ophthalmic Solution, 0.00267%<br>* Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose<br>|
| Active Comparator: TRAVATAN<br>Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals) | Drug: Travoprost Ophthalmic Solution, 0.004%<br> <br> * Other names: TRAVATAN®;|
| Placebo Comparator: Vehicle<br>Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days | Drug: Travoprost Vehicle<br>* Inactive ingredients used as an active comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Area Under the Curve (AUC) in IOP Reduction |  | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open-angle glaucoma, ocular hypertension, divided dose