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

NCT ID: NCT01978600

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-03-31

Brief Summary

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

Detailed 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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SIMBRINZA™

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

Group Type: EXPERIMENTAL

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension

Intervention Type: DRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Timolol Maleate 0.5%

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

Group Type: ACTIVE_COMPARATOR

Timolol Maleate 0.5%

Intervention Type: DRUG

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Interventions

Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Intervention Type: DRUG

Timolol Maleate 0.5%

Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.

Intervention Type: DRUG

Other Intervention Names

SIMBRINZA™; TIMOPTIC™; TIMOPTIC-XE™; BETIMOL™; ISTALOL™

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danyel Carr, MS

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-13-037

Identifier Type: -

Identifier Source: org_study_id