Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue

NCT01937312 | Completed Phase 4 Results

• 1 other identifier: M-13-020
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Keywords

glaucoma; prostaglandin analogue; brinzolamide; brimonidine

Outcome Measures

Primary Outcomes (1)

• Mean Diurnal Intraocular Pressure (IOP) at Week 6

  Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

  Week 6

Secondary Outcomes (3)

• Mean Diurnal IOP Change From Baseline to Week 6

  Baseline, Week 6

• Mean Diurnal IOP Percentage Change From Baseline to Week 6

  Baseline, Week 6

• Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)

  Week 6

Study Arms (2)

SIMBRINZA

EXPERIMENTAL

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks

Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Drug: Prostaglandin analogue

Vehicle

PLACEBO COMPARATOR

Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks

Drug: Vehicle; Drug: Prostaglandin analogue

Interventions

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension DRUG

Also known as: SIMBRINZA® Suspension

SIMBRINZA

Vehicle DRUG

Inactive ingredients used as a placebo comparator

Vehicle

Prostaglandin analogue DRUG

Also known as: TRAVATAN Z®, LUMIGAN®, XALATAN®

SIMBRINZA; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
• Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \<32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
• Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
• Able to understand and sign Informed Consent Document;

You may not qualify if:

• Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
• Any form of glaucoma other than open angle glaucoma or ocular hypertension;
• Severe central visual field loss;
• Chronic, recurrent, or severe inflammatory eye disease;
• Ocular trauma within the past 6 months;
• Ocular infection or ocular inflammation within the past 3 months;
• Best-corrected visual acuity score worse than approximately 20/80 Snellen;
• Eye surgery within the past 6 months;
• Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
• Use of any additional topical or systemic ocular hypertensive medication during the study;
• Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle; Glaucoma

Interventions

brinzolamide; Brimonidine Tartrate; Prostaglandins, Synthetic; Travoprost; Bimatoprost; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cloprostenol; Prostaglandins F, Synthetic; Amides; Organic Chemicals

Results Point of Contact

• Title: Global Brand Leader, Medical Affairs, Glaucoma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Steve Burmaster, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 28, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-07