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Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

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ClinicalTrials.gov Identifier: NCT01937312
Recruitment Status : Completed
First Posted : September 9, 2013
Results First Posted : June 8, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension Drug: Vehicle Drug: Prostaglandin analogue Phase 4

Detailed Description:
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
Study Start Date : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014


Arm Intervention/treatment
Experimental: SIMBRINZA
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Other Name: SIMBRINZA® Suspension

Drug: Prostaglandin analogue
Other Names:
  • TRAVATAN Z®
  • LUMIGAN®
  • XALATAN®

Placebo Comparator: Vehicle
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Drug: Vehicle
Inactive ingredients used as a placebo comparator

Drug: Prostaglandin analogue
Other Names:
  • TRAVATAN Z®
  • LUMIGAN®
  • XALATAN®




Primary Outcome Measures :
  1. Mean Diurnal Intraocular Pressure (IOP) at Week 6 [ Time Frame: Week 6 ]
    Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).


Secondary Outcome Measures :
  1. Mean Diurnal IOP Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.

  2. Mean Diurnal IOP Percentage Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
    Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.

  3. Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM) [ Time Frame: Week 6 ]
    IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
  • Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
  • Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
  • Able to understand and sign Informed Consent Document;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
  • Any form of glaucoma other than open angle glaucoma or ocular hypertension;
  • Severe central visual field loss;
  • Chronic, recurrent, or severe inflammatory eye disease;
  • Ocular trauma within the past 6 months;
  • Ocular infection or ocular inflammation within the past 3 months;
  • Best-corrected visual acuity score worse than approximately 20/80 Snellen;
  • Eye surgery within the past 6 months;
  • Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
  • Use of any additional topical or systemic ocular hypertensive medication during the study;
  • Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
  • Other protocol-defined exclusion criteria may apply.

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): NCT01937312


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Steve Burmaster, PhD Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01937312     History of Changes
Other Study ID Numbers: M-13-020
First Posted: September 9, 2013    Key Record Dates
Results First Posted: June 8, 2015
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Alcon Research:
glaucoma
prostaglandin analogue
brinzolamide
brimonidine
Additional relevant MeSH terms:
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Brimonidine Tartrate
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Brinzolamide
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors