Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol Maleate 0.5%; Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01978600

M-13-037

Details and patient eligibility

About

The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.

Full description

This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
• Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
• Must sign an Informed Consent form.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
• Severe central visual field loss in either eye.
• Chronic, recurrent or severe inflammatory eye disease.
• Ocular trauma or ocular surgery within the past 6 months.
• Ocular infection or ocular inflammation within the past 3 months.
• Clinically significant or progressive retinal disease.
• Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
• Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
• Any medical condition that would preclude the safe administration of a topical beta-blocker.
• Cannot safely discontinue all glucocorticoids administered by any route.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups

SIMBRINZA™

Experimental group

Description:

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks

Treatment:

Drug: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension

Timolol Maleate 0.5%

Active Comparator group

Description:

Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks

Treatment:

Drug: Timolol Maleate 0.5%