Back to resultsA Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Primary Purpose
Glaucoma
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution formulation A
timolol ophthalmic solution
bimatoprost vehicle
Sponsored by
About this trial
This is an interventional treatment trial for 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bimatoprost ophthalmic solution formulation A and vehicle
timolol ophthalmic solution
Arm Description
1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01426113
Brief Title
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to corporate decision.
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost ophthalmic solution formulation A and vehicle
Arm Type
Experimental
Arm Description
1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
Arm Title
timolol ophthalmic solution
Arm Type
Active Comparator
Arm Description
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution formulation A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
timolol ophthalmic solution
Intervention Description
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
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.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Louisville
State/Province
Kentucky
Country
United States
City
Amiens
Country
France
City
Milan
Country
Italy
City
Parma
Country
Italy
City
Seoul
Country
Korea, Republic of
City
Makati
Country
Philippines
City
Taguig
Country
Philippines
City
Taipei
Country
Taiwan
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
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