24-hr Intraocular Pressure Control With SIMBRINZA ®

NCT02770248 | Completed Phase 4 Results

• 1 other identifier: GLT320a-P001
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at 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.

  Baseline (Day 0), Week 4

Secondary Outcomes (3)

• Least Squares Mean Change From Baseline in Daytime IOP at Week 4

  Baseline (Day 0), Week 4

• Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4

  Baseline (Day 0), Week 4

• Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4

  Baseline (Day 0), Week 4

Study Arms (2)

SIMBRINZA

EXPERIMENTAL

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

Vehicle

ACTIVE COMPARATOR

Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days

Drug: Vehicle

Interventions

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension DRUG

Also known as: SIMBRINZA ®

SIMBRINZA

Vehicle DRUG

Inactive ingredients used as a placebo for masking purposes

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma

Interventions

brinzolamide; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Field Medical, Ophthalmology
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 12, 2016
• Study Start: May 23, 2016
• Primary Completion: January 14, 2017
• Study Completion: January 14, 2017
• Last Updated: July 2, 2018
• Results First Posted: January 4, 2018

Record last verified: 2018-01