Status:
TERMINATED
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Lead Sponsor:
Allergan
Conditions:
Glaucoma
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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 w...
Eligibility Criteria
Inclusion
- Diagnosis of congenital, juvenile glaucoma
- Requires treatment with IOP-lowering medication in one or both eyes
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01426113
Start Date
September 1 2011
End Date
October 1 2014
Last Update
October 2 2015
Active Locations (9)
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1
Louisville, Kentucky, United States
2
Amiens, France
3
Milan, Italy
4
Parma, Italy