Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217606
• Other study ID #: 192024-062
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2010
• Last updated: October 12, 2015
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency (ANVISA)
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ocular hypertension or primary open-angle glaucoma in each eye

• Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

• Required chronic use of ocular medications during the study other than study medication

• Use of any corticosteroids within 30 days

• History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit

• Anticipated wearing of contact lenses during the study

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
• Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP)	Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).	Baseline, Week 12	No