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

• ClinicalTrials.gov Identifier: NCT01241240
• Recruitment Status: Completed
• First Posted: November 16, 2010
• Results First Posted: September 10, 2014
• Last Update Posted: September 10, 2014
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief 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.

Condition or disease	Intervention/treatment	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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: March 2011
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12 [ Time Frame: Baseline, Week 12 ]
   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 :

1. Change From Baseline in Mean Worse Eye IOP [ Time Frame: Baseline, Weeks 1, 2, 4 and 8 ]
   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.
2. Mean Worse Eye IOP [ Time Frame: Weeks 1, 2, 4, 8 and 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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 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

Locations

Colombia

Bogotá, Colombia

Mexico

Mexico City, Mexico

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01241240
• Other Study ID Numbers: 192024-063
• First Posted: November 16, 2010
• Results First Posted: September 10, 2014
• Last Update Posted: September 10, 2014
• Last Verified: September 2014

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Timolol; Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions; 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