Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229462
• Other study ID #: 190342-035
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: August 15, 2012
• Start date: October 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Food and Drug Administration P.R. China (SFDA)
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers

• No anticipated wearing of contact lenses during study

Exclusion Criteria:

• Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)

• Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months

• Required regular use of other ocular medications except for occasional use of artificial tears

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• brimonidine tartrate/timolol fixed combination ophthalmic solution
One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
• brimonidine tartrate ophthalmic solution
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
• timolol ophthalmic solution
One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Other:
• fixed combination vehicle
Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4	Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).	Baseline, Week 4	No