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

• Status: Terminated
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Bimatoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

Criteria

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)