SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)

Ocular Hypertension Clinical Trial

Official title:

Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419508
• Other study ID #: GLH694-P001
• Secondary ID: 2015-000736-15RE
• Status: Completed
• Phase: Phase 4
• Start date: August 7, 2015
• Est. completion date: February 27, 2018

Study information

• Verified date: November 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 the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.

Description:

This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: February 27, 2018
• Est. primary completion date: February 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of either open-angle glaucoma or ocular hypertension;

• Must sign an informed consent form;

• Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) = 19 and < 32 mmHg at 09:00.

• Willing and able to attend all study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;

• Any form of glaucoma other than open-angle glaucoma or ocular hypertension;

• Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;

• Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;

• Other protocol-specified exclusion criteria may apply.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

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

• Brinz/brim vehicle
Inactive ingredients used as a placebo for masking purposes
• Prostaglandin analogue

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Secondary	Mean Diurnal IOP at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.	Week 6
Secondary	Mean Percentage Change From Baseline in Diurnal IOP at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Secondary	Mean Change From Baseline in IOP at 11:00 at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Secondary	Mean Percentage Change From Baseline in IOP at 11:00 at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Secondary	Mean Change From Baseline in IOP at 09:00 at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6
Secondary	Mean Percentage Change From Baseline at 09:00 at Week 6	IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.	Baseline, Week 6

External Links

•   Results from the Novartis Clinical Trial Results Website