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

Phase 3

Terminated

• Conditions: Glaucoma
• Interventions: Drug: bimatoprost ophthalmic solution formulation A; Drug: timolol ophthalmic solution; Drug: bimatoprost vehicle

• Registration Number: NCT01426113
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-31
• Study Start: 2011-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-06-29
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-02
• Last Update Submitted: 2015-09-02
• Results First Posted: 2015-10-02
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost ophthalmic solution formulation A and vehicle	bimatoprost ophthalmic solution formulation A	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.
bimatoprost ophthalmic solution formulation A and vehicle	bimatoprost 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.
timolol ophthalmic solution	timolol ophthalmic solution	1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	Baseline, Week 6	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.