Trial Outcomes & Findings for A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma (NCT NCT01426113)
NCT ID: NCT01426113
Last Updated: 2015-10-02
Results Overview
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.
TERMINATED
PHASE3
6 participants
Baseline, Week 6
2015-10-02
Participant Flow
The study was discontinued prematurely after enrollment of 6 patients.
Participant milestones
| Measure |
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.
|
Timolol Ophthalmic Solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Timolol Ophthalmic Solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
|
|---|---|---|
|
Overall Study
Study Discontinued
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Baseline characteristics by cohort
| Measure |
Bimatoprost Ophthalmic Solution Formulation A and Vehicle
n=3 Participants
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.
|
Timolol Ophthalmic Solution
n=3 Participants
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12 to 15 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: 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.
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 measures
Outcome data not reported
Adverse Events
Bimatoprost Ophthalmic Solution Formulation A and Vehicle
Timolol Ophthalmic Solution
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bimatoprost Ophthalmic Solution Formulation A and Vehicle
n=3 participants at risk
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.
|
Timolol Ophthalmic Solution
n=3 participants at risk
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
|
|---|---|---|
|
Eye disorders
Eyelash Hyperpigmentation
|
0.00%
0/3
|
33.3%
1/3
|
|
Eye disorders
Growth of Eyelashes
|
33.3%
1/3
|
33.3%
1/3
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/3
|
33.3%
1/3
|
|
Eye disorders
Conjunctival Hyperaemia
|
66.7%
2/3
|
0.00%
0/3
|
|
Eye disorders
Eyelid Oedema
|
33.3%
1/3
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
0.00%
0/3
|
|
Infections and infestations
Influenza
|
33.3%
1/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
33.3%
1/3
|
0.00%
0/3
|
|
Eye disorders
Blepharal Pigmentation
|
33.3%
1/3
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER