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

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Drug: Prostaglandin analogue; Drug: Brinz/brim vehicle

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIMBRINZA + PGA; Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days	Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension; Other Names: SIMBRINZA® suspension; Drug: Prostaglandin analogue; Other Names: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%); LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%); XALATAN® (Latanoprost ophthalmic solution, 0.005%)
Other: Vehicle + PGA; Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days	Drug: Prostaglandin analogue; Other Names: TRAVATAN® PQ (Travoprost ophthalmic solution with PQ, 0.004%); LUMIGAN® (Bimatoprost ophthalmic solution, 0.01%); XALATAN® (Latanoprost ophthalmic solution, 0.005%); Drug: Brinz/brim vehicle; Inactive ingredients used as a placebo for masking purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Ophtha, GCRA, Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2015
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Carbonic Anhydrase Inhibitors; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Brinzolamide; Bimatoprost; Latanoprost
• Other Study ID Numbers: GLH694-P001; 2015-000736-15 (EudraCT Number); REec-2015-1723 (Registry Identifier: Registro Espanol de Estudios Clinicos)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes