24-hr Intraocular Pressure Control With SIMBRINZA ®

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770248
• Other study ID #: GLT320a-P001
• Status: Completed
• Phase: Phase 4
• Start date: May 23, 2016
• Est. completion date: January 14, 2017

Study information

• Verified date: January 2018
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 14, 2017
• Est. primary completion date: January 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

• Vehicle
Inactive ingredients used as a placebo for masking purposes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Least Squares Mean Change From Baseline in Daytime IOP at 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.	Baseline (Day 0), Week 4
Secondary	Least Squares Mean Change From Baseline in Nocturnal IOP at 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.	Baseline (Day 0), Week 4
Secondary	Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at 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.	Baseline (Day 0), Week 4

External Links

•   Results from the Novartis Clinical Trial Results Website