A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: bimatoprost ophthalmic solution formulation A
* Drug: timolol ophthalmic solution
* Drug: bimatoprost vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of congenital, juvenile glaucoma Requires treatment with IOP-lowering medication in one or both eyes Exclusion Criteria: Surgical intervention is indicated or planned to lower IOP Abnormally low body weight (below 5th percentile) Any active eye infection or disease Anticipated use of contact lenses during the study Topical ocular steroid use within 2 months History of ocular trauma in either eye Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bimatoprost ophthalmic solution formulation A and vehicle<br>1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. | Drug: bimatoprost ophthalmic solution formulation A<br>* 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.<br>Drug: bimatoprost vehicle<br>* 1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.<br>|
| Active Comparator: timolol ophthalmic solution<br>1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. | Drug: timolol ophthalmic solution<br>* 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure. | Baseline, Week 6 |