Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®

NCT01937299 | Completed Phase 4 Results

• 1 other identifier: M-13-019
• Study Type: interventional
• Target: 307
• 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 (TRAVATAN Z®).

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 analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

  Week 6

Secondary Outcomes (2)

• 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

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 travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks

Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Drug: Travoprost 0.004% ophthalmic solution

Vehicle

PLACEBO COMPARATOR

Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks

Drug: Vehicle; Drug: Travoprost 0.004% ophthalmic solution

Interventions

Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension DRUG

Also known as: SIMBRINZA®

SIMBRINZA

Vehicle DRUG

Inactive ingredients used as a placebo comparator

Vehicle

Travoprost 0.004% ophthalmic solution DRUG

Also known as: TRAVATAN Z®

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 or ocular hypertension;
• Mean IOP measurements in at least 1 eye (study eye) of ≥ 21 mmHg and \<32 mmHg at 8 AM while on travoprost monotherapy at 2 consecutive visits (Eligibility 1 and Eligibility 2);
• Able to understand and sign Informed Consent form;

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; Travoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Doug Hubatsch, 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: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2015
• Results First Posted: May 14, 2015

Record last verified: 2015-04