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

• ClinicalTrials.gov Identifier: NCT01937312
• Recruitment Status: Completed
• First Posted: September 9, 2013
• Results First Posted: June 8, 2015
• Last Update Posted: July 28, 2015
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ocular Hypertension; Open Angle Glaucoma	Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Drug: Vehicle; Drug: Prostaglandin analogue	Phase 4

Detailed Description:

This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 282 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
• Study Start Date: October 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: SIMBRINZA; 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; Other Name: SIMBRINZA® Suspension; Drug: Prostaglandin analogue; Other Names: TRAVATAN Z®; LUMIGAN®; XALATAN®
Placebo Comparator: Vehicle; 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; Inactive ingredients used as a placebo comparator; Drug: Prostaglandin analogue; Other Names: TRAVATAN Z®; LUMIGAN®; XALATAN®

Outcome Measures

Primary Outcome Measures :

1. Mean Diurnal Intraocular Pressure (IOP) at Week 6 [ Time Frame: 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).

Secondary Outcome Measures :

1. Mean Diurnal IOP Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
   Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 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 more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.
2. Mean Diurnal IOP Percentage Change From Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]
   Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 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 more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.
3. Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM) [ Time Frame: Week 6 ]
   IOP was assessed using Goldmann applanation tonometry and reported in 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).

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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;
• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Steve Burmaster, PhD; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01937312
• Other Study ID Numbers: M-13-020
• First Posted: September 9, 2013
• Results First Posted: June 8, 2015
• Last Update Posted: July 28, 2015
• Last Verified: July 2015

Keywords provided by Alcon Research:

glaucoma; prostaglandin analogue; brinzolamide; brimonidine

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Brimonidine Tartrate; Travoprost; Brinzolamide; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors