A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01426113
• Collaborator: (none)
• Enrollment: 6
• Locations: 9
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: bimatoprost ophthalmic solution formulation A; Drug: timolol ophthalmic solution; Drug: bimatoprost vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: bimatoprost 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.; Drug: bimatoprost vehicle; 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.
Active Comparator: timolol ophthalmic solution 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.	Drug: timolol ophthalmic solution; 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Louisville	Kentucky	United States
2		Amiens		France
3		Milan		Italy
4		Parma		Italy
5		Seoul		Korea, Republic of
6		Makati		Philippines
7		Taguig		Philippines
8		Taipei		Taiwan
9		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01426113
• Other Study ID Numbers: 192024-056
• First Posted: Aug 31, 2011
• Last Update Posted: Oct 2, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Glaucoma; Timolol; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	The study was discontinued prematurely after enrollment of 6 patients.

Arm/Group Title	Bimatoprost Ophthalmic Solution Formulation A and Vehicle	Timolol Ophthalmic Solution
Arm/Group 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.
Period Title: Overall Study
STARTED	3	3
COMPLETED	2	1
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Bimatoprost Ophthalmic Solution Formulation A and Vehicle	Timolol Ophthalmic Solution	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	3	3	6
Age, Customized (Number) [Number]
12 to 15 years	3 100%	3 100%	6 100%
Sex: Female, Male (Count of Participants)
Female	3 100%	0 0%	3 50%
Male	0 0%	3 100%	3 50%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimatoprost Ophthalmic Solution Formulation A and Vehicle	Timolol Ophthalmic Solution
Arm/Group 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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Bimatoprost Ophthalmic Solution Formulation A and Vehicle		Timolol Ophthalmic Solution
Arm/Group 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.
All Cause Mortality
	Bimatoprost Ophthalmic Solution Formulation A and Vehicle		Timolol Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost Ophthalmic Solution Formulation A and Vehicle		Timolol Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost Ophthalmic Solution Formulation A and Vehicle		Timolol Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		1/3 (33.3%)
Eye disorders
Eyelash Hyperpigmentation	0/3 (0%)		1/3 (33.3%)
Growth of Eyelashes	1/3 (33.3%)		1/3 (33.3%)
Conjunctival Hyperaemia	2/3 (66.7%)		0/3 (0%)
Eyelid Oedema	1/3 (33.3%)		0/3 (0%)
Blepharal Pigmentation	1/3 (33.3%)		0/3 (0%)
Gastrointestinal disorders
Diarrhoea	1/3 (33.3%)		0/3 (0%)
General disorders
Pyrexia	1/3 (33.3%)		0/3 (0%)
Infections and infestations
Influenza	1/3 (33.3%)		0/3 (0%)
Investigations
Intraocular Pressure Increased	0/3 (0%)		1/3 (33.3%)
Nervous system disorders
Headache	1/3 (33.3%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.