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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01426113
• Other study ID #: 192024-056
• Status: Terminated
• Phase: Phase 3
• First received: August 29, 2011
• Last updated: September 2, 2015
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.
• timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  France,  Italy,  Korea, Republic of,  Philippines,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Week 6	No