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

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 9, 2013
Results First Submitted Date  ICMJE May 22, 2015
Results First Posted Date  ICMJE June 8, 2015
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
Mean Diurnal Intraocular Pressure (IOP) [ Time Frame: Week 6 ]
Diurnal IOP is defined as the mean of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • Change from Baseline in Mean Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
    Diurnal IOP is defined as the mean of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
  • Percentage Change from Baseline in Mean Diurnal IOP at Week 6 [ Time Frame: Baseline, Week 6 ]
    Diurnal IOP is defined as the mean of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Official Title  ICMJE Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ocular Hypertension
  • Open Angle Glaucoma
Intervention  ICMJE
  • Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
    Other Name: SIMBRINZA® Suspension
  • Drug: Vehicle
    Inactive ingredients used as a placebo comparator
  • Drug: Prostaglandin analogue
    Other Names:
    • TRAVATAN Z®
    • LUMIGAN®
    • XALATAN®
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
    • Drug: Prostaglandin analogue
  • 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
    Interventions:
    • Drug: Vehicle
    • Drug: Prostaglandin analogue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
282
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
200
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01937312
Other Study ID Numbers  ICMJE M-13-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steve Burmaster, PhD Alcon Research
PRS Account Alcon Research
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP