Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.

Official Title
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A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

Conditions
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Pediatric Glaucoma, Elevated IOP in Pediatric Patients, Ocular Hypertension in Pediatric Patients

Intervention / Treatment
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* Drug: Travoprost 0.004% PQ ophthalmic solution
* Drug: Timolol, 0.5% or 0.25% ophthalmic solution
* Drug: Travoprost Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pediatric glaucoma or ocular hypertension. Qualifying mean IOP at the Eligibility Visit in at least one eye. Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures. History of chronic, recurrent or severe inflammatory eye disease. Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit. Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit. Clinically significant or progressive retinal disease. Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker. Intraocular surgery in the study eye within 30 days prior to the Screening Visit. Any abnormality preventing reliable applanation tonometry. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 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: Travoprost<br>Travoprost 0.004% PQ ophthalmic solution, 1 drop administered in each eye in the evening with travoprost vehicle administered once daily in the morning for 3 months | Drug: Travoprost 0.004% PQ ophthalmic solution<br> <br> Drug: Travoprost Vehicle<br>* Inactive ingredients used to maintain masking<br>|
| Active Comparator: Timolol<br>Timolol, 0.5% or 0.25% ophthalmic solution, 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months | Drug: Timolol, 0.5% or 0.25% ophthalmic solution<br>* Patients 2 months to < 3 years of age received 0.25%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in IOP at Month 3 | IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis. | Baseline (Day 0), Month 3 |