NCT01426113

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 2 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-08-31
• Last updated: 2015-10-02
• Results posted: 2015-10-02

Locations

9 sites across 7 countries: United States, France, Italy, Philippines, South Korea, Taiwan, United Kingdom