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24-hr Intraocular Pressure Control With SIMBRINZA ®

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Status and phase

Completed
Phase 4

Conditions

Glaucoma

Treatments

Drug: Vehicle
Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770248
GLT320a-P001

Details and patient eligibility

About

The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.

Full description

Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of either open-angle glaucoma or ocular hypertension;
  • Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
  • Willing and able to sign an informed consent form;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
  • Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
  • Ocular surgeries or procedures excluded by the protocol;
  • Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
  • Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
  • Other protocol-specific exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

162 participants in 2 patient groups

SIMBRINZA
Experimental group
Description:
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Treatment:
Drug: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension
Vehicle
Active Comparator group
Description:
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
Treatment:
Drug: Vehicle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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