Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:September 2012
End Date:November 2012
Contact:Aron Shapiro
Email:ashapiro@oraclinical.com

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A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension


The purpose of this study is to determine the intraocular Pressure (IOP) lowering response
and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects
with open angle glaucoma or ocular hypertension.


Inclusion Criteria:

- Be at least 18 years of age at Visit 1 (Screening), of either sex and any race

- Be willing and able to provide written informed consent prior to any study procedures
being performed.

- Be willing and able to follow all instructions and attend all study visits.

- Be willing to discontinue use of disallowed medication

- Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic
angle closure glaucoma with a patent iridotomy.

Exclusion Criteria:

- Have known sensitivity or poor tolerance to brimonidine or any other component of the
study medications.

- Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or
chronic angle closure glaucoma with patent iridotomy.
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Boston, Massachusetts 02114
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