Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

Glaucoma, Angle-Closure Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01151904
• Other study ID #: MA-COM004
• Status: Terminated
• Phase: Phase 4
• First received: June 5, 2010
• Last updated: January 3, 2013
• Start date: November 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study

• Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops

• Diagnosis of chronic angle-closure glaucoma

• Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Exclusion Criteria:

• Known allergy or hypersensitivity to COMBIGAN®

• Corneal abnormalities that would preclude accurate IOP readings

• Any other active ocular disease other than glaucoma or ocular hypertension

• Ocular surgery within the past 3 months.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Drug:
• brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution
COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
• latanoprost
Latanoprost administered in the affected eye(s) as prescribed by physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP)	IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.	Baseline, Week 12	No
Secondary	Change From Baseline in IOP	IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.	Baseline, Week 2, Week 6	No
Secondary	Percentage of Responders With an IOP Reduction =20% From Baseline	IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.	Baseline, Week 12	No