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

Phase 3TerminatedNCT01426113

Allergan6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glaucoma

Interventions

bimatoprost ophthalmic solution formulation ADRUG

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.

timolol ophthalmic solutionDRUG

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

bimatoprost vehicleDRUG

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (9)

Unnamed facility

Louisville, Kentucky, United States

Unnamed facility

Amiens, France

Unnamed facility

Milan, Italy

Unnamed facility

Parma, Italy

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

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