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24-hr Intraocular Pressure Control With SIMBRINZA ®

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: NCT02770248
Recruitment Status : Completed
First Posted : May 12, 2016
Results First Posted : January 4, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension Drug: Vehicle Phase 4

Detailed Description:
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle
Actual Study Start Date : May 23, 2016
Actual Primary Completion Date : January 14, 2017
Actual Study Completion Date : January 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: SIMBRINZA
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Other Name: SIMBRINZA ®

Active Comparator: Vehicle
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Drug: Vehicle
Inactive ingredients used as a placebo for masking purposes




Primary Outcome Measures :
  1. Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Least Squares Mean Change From Baseline in Daytime IOP at Week 4 [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

  2. Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4 [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.

  3. Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4 [ Time Frame: Baseline (Day 0), Week 4 ]
    IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.



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 either open-angle glaucoma or ocular hypertension;
  • Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
  • Willing and able to sign an informed consent form;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
  • Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
  • Ocular surgeries or procedures excluded by the protocol;
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
  • Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
  • Other protocol-specific 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): NCT02770248


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, GCRA Alcon Research

Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02770248    
Other Study ID Numbers: GLT320a-P001
First Posted: May 12, 2016    Key Record Dates
Results First Posted: January 4, 2018
Last Update Posted: July 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate
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