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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01217606
First Posted: October 8, 2010
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) Drug: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test [ Time Frame: Baseline, Week 12 ]
    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) Hour 0 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). Data are analyzed using a two-sample t-test.


Secondary Outcome Measures:
  • Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 ]
    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) Hour 0 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). Data are analyzed by a mixed-effect model for repeated measure.

  • Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA) [ Time Frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12 ]
    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). Data are analyzed by ANCOVA.


Enrollment: 185
Study Start Date: January 2011
Study Completion Date: June 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triple Combination Therapy
Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
Drug: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)
One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
Active Comparator: Combigan®
Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
Drug: 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 up to 12 months.
Other Name: COMBIGAN®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 traumatic eye surgeries
  • Cataract surgery in the past 6 months
  • Anticipated wearing of contact lenses during the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217606


Locations
Brazil
São Paulo, Brazil
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01217606     History of Changes
Other Study ID Numbers: 192024-062
First Submitted: October 7, 2010
First Posted: October 8, 2010
Results First Submitted: October 12, 2015
Results First Posted: November 9, 2015
Last Update Posted: December 20, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Brimonidine Tartrate, Timolol Maleate Drug Combination
Bimatoprost
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists