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 with glaucoma.
Brief Title
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Completion Date
Completion Date Type
Actual
Conditions
Glaucoma
Eligibility 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)
* 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)
Inclusion Criteria
Inclusion Criteria:
* Diagnosis of congenital, juvenile glaucoma
* Requires treatment with IOP-lowering medication in one or both eyes
* Diagnosis of congenital, juvenile glaucoma
* Requires treatment with IOP-lowering medication in one or both eyes
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
2 Months
NCT Id
NCT01426113
Org Class
Industry
Org Full Name
Allergan
Org Study Id
192024-056
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Primary Outcomes
Outcome Description
IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.
Outcome Measure
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Outcome Time Frame
Baseline, Week 6
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Norman Medow
Investigator Email
nmedow@montefiore.org
Investigator Phone