Glaucoma
Conditions
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.
Interventions
DRUGbimatoprost 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.
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
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.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | Baseline, Week 6 | 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. |
Countries
France, Italy, Philippines, South Korea, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The study was discontinued prematurely after enrollment of 6 patients.
Participants by arm
| Arm | Count |
|---|---|
| Bimatoprost Ophthalmic Solution Formulation A and Vehicle 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. | 3 |
| Timolol Ophthalmic Solution 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Study Discontinued | 1 | 1 |
Baseline characteristics
| Characteristic | Bimatoprost Ophthalmic Solution Formulation A and Vehicle | Timolol Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Customized 12 to 15 years | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
Primary
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.
Time frame: Baseline, Week 6
Population: Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled.