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

Stopped early · Phase 3

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01426113

Run by

Allergan

People needed

6

Starts

2011-09-01

Expected to finish

2014-10-01

Last updated by the study team

2015-10-02

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of congenital, juvenile glaucoma
• Requires treatment with IOP-lowering medication in one or both eyes

You may not qualify if…

• 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)

Where it is running

• Study site — Louisville, Kentucky, United States
• Study site — Amiens, France
• Study site — Milan, Italy
• Study site — Parma, Italy
• Study site — City of Taguig, Philippines
• Study site — Makati, Philippines
• Study site — Seoul, South Korea
• Study site — Taipei, Taiwan
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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