- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01297517
Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
May 14, 2013 updated by: Alcon Research
Three Month Efficacy and Safety Study of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.
Study Overview
Status
Completed
Conditions
Detailed Description
This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months.
Study drug instillation began the morning after the second eligibility visit.
Study Type
Interventional
Enrollment (Actual)
1001
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Sign Informed Consent document.
- Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- Any form of glaucoma other than open-angle glaucoma.
- Severe central vision loss in either eye.
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or ocular inflammation within the preceding 3 months.
- Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
- Ocular surgery within the preceding 6 months.
- Ocular laser surgery within the preceding 3 months.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
- Other protocol-specified exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brinzolamide/Brimonidine
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
|
|
Active Comparator: Brinzolamide
Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
|
Other Names:
|
Active Comparator: Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
Time Frame: Month 3
|
At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug.
The study drug was instilled approximately 15 minutes after the 8 am measurement.
An additional dose was given at 3 pm.
Intraocular pressure was measured by Goldmann applanation tonometry.
One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis.
A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
|
Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: James Teague, BS, Sr. Clinical Manager, Alcon Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
February 15, 2011
First Submitted That Met QC Criteria
February 15, 2011
First Posted (Estimate)
February 16, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 14, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Brimonidine Tartrate
- Ophthalmic Solutions
- Brinzolamide
Other Study ID Numbers
- C-10-033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ocular Hypertension
-
Western Galilee Hospital-NahariyaUnknown
-
Laboratoires TheaCompletedOcular Hypertension GlaucomaBulgaria
-
Santen Inc.Completed
-
West Virginia UniversityUniversity of PittsburghRecruitingGlaucoma and Ocular HypertensionUnited States, United Kingdom, Canada
-
University Hospital, GenevaTerminatedGlaucoma and Ocular HypertensionSwitzerland
-
Santen Inc.Completed
-
Maastricht University Medical CenterCompletedCorticosteroid Induced Ocular Hypertension/GlaucomaNetherlands
-
Santen Inc.CompletedA Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHTGlaucoma and Ocular HypertensionUnited States
-
Bausch & Lomb IncorporatedCompletedGlaucoma | Open Angle or Ocular HypertensionUnited States
-
Nicox Ophthalmics, Inc.CompletedGlaucoma, Open-Angle | Hypertension, OcularUnited States
Clinical Trials on Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Alcon ResearchTerminatedOcular Hypertension | Open-Angle Glaucoma
-
Alcon ResearchCompletedOcular Hypertension | Open-Angle Glaucoma
-
Padagis LLCCompletedOcular Hypertension | Glaucoma, Open-AngleUnited States
-
General Hospital of Athens ElpisCompletedEye Diseases | Intraocular Pressure | Injection ComplicationGreece
-
Alcon ResearchTerminatedOcular Hypertension | Open-angle GlaucomaUnited States
-
University Hospital of PatrasCompletedOcular Hypertension | Posterior Capsule OpacificationGreece