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

Alcon

Status and phase: Completed; Phase 4

Conditions: Open Angle Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01937299

M-13-019

Details and patient eligibility

About

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®).

Full 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®, 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).

Enrollment: 307 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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307 participants in 2 patient groups, including a placebo group

SIMBRINZA

Experimental group

Description:

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

Treatment:

Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension

Drug: Travoprost 0.004% ophthalmic solution

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Travoprost 0.004% ophthalmic solution

Drug: Vehicle