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

Allergan

Status and phase: Terminated; Phase 3

Conditions: Glaucoma

Treatments: Drug: timolol ophthalmic solution; Drug: bimatoprost ophthalmic solution formulation A; Drug: bimatoprost vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426113

192024-056

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

bimatoprost ophthalmic solution formulation A and vehicle

Experimental group

Description:

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.

Treatment:

Drug: bimatoprost ophthalmic solution formulation A

Drug: bimatoprost vehicle

timolol ophthalmic solution

Active Comparator group

Description:

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

Treatment:

Drug: timolol ophthalmic solution