24-hr Intraocular Pressure Control With SIMBRINZA ®

24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle

Sponsors

Lead Sponsor: Alcon Research

Source 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.

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.

Overall Status Completed
Start Date 2016-05-23
Completion Date 2017-01-14
Primary Completion Date 2017-01-14
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4 Baseline (Day 0), Week 4
Secondary Outcome
Measure Time Frame
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
Enrollment 162
Condition
Intervention

Intervention Type: Drug

Intervention Name: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Arm Group Label: SIMBRINZA

Other Name: SIMBRINZA ®

Intervention Type: Drug

Intervention Name: Vehicle

Description: Inactive ingredients used as a placebo for masking purposes

Arm Group Label: Vehicle

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; - 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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Clinical Manager, GCRA Study Director Alcon Research
Verification Date

2018-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: SIMBRINZA

Type: Experimental

Description: 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

Label: Vehicle

Type: Active Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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