24-hr Intraocular Pressure Control With SIMBRINZA ®

NCT ID: NCT02770248

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-23
• Study Completion Date: 2017-01-14

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.

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Intervention Type: DRUG

Vehicle

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

Group Type: ACTIVE_COMPARATOR

Vehicle

Intervention Type: DRUG

Inactive ingredients used as a placebo for masking purposes

Interventions

Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Intervention Type: DRUG

Vehicle

Inactive ingredients used as a placebo for masking purposes

Intervention Type: DRUG

Other Intervention Names

SIMBRINZA ®

Eligibility 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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

GLT320a-P001

Identifier Type: -

Identifier Source: org_study_id