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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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bimatoprost ophthalmic solution formulation A and vehicle

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.

Group Type EXPERIMENTAL

bimatoprost ophthalmic solution formulation A

Intervention Type DRUG

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.

bimatoprost vehicle

Intervention Type DRUG

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.

timolol ophthalmic solution

1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Group Type ACTIVE_COMPARATOR

timolol ophthalmic solution

Intervention Type DRUG

1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Interventions

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bimatoprost ophthalmic solution formulation A

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.

Intervention Type DRUG

timolol ophthalmic solution

1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Intervention Type DRUG

bimatoprost vehicle

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.

Intervention Type DRUG

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)

Minimum Eligible Age

2 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No