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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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01241240
First received: November 12, 2010
Last updated: September 4, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.


Secondary Outcome Measures:
  • Change From Baseline in Mean Worse Eye IOP [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.

  • Mean Worse Eye IOP [ Time Frame: Weeks 1, 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.


Enrollment: 192
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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 12 weeks.
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.
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 12 weeks.
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 12 weeks.
Other Name: COMBIGAN®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241240

Locations
Colombia
Bogotá, Colombia
Mexico
Mexico City, Mexico
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01241240     History of Changes
Other Study ID Numbers: 192024-063
Study First Received: November 12, 2010
Results First Received: September 4, 2014
Last Updated: September 4, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks (COFEPRIS)

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

ClinicalTrials.gov processed this record on November 27, 2014