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

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Alcon

Status and phase

Completed
Phase 4

Conditions

Open Angle Glaucoma
Ocular Hypertension

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01937312
M-13-020

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.

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®, 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).

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

282 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 prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
Treatment:
Drug: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension
Drug: Prostaglandin analogue
Vehicle
Placebo Comparator group
Description:
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
Treatment:
Drug: Vehicle
Drug: Prostaglandin analogue

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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