24-hr Intraocular Pressure Control With SIMBRINZA ®

• 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: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

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:

• 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.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Clinical Manager, GCRA; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02770248
• Other Study ID Numbers: GLT320a-P001
• First Posted: May 12, 2016
• 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:

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