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

Information source: Eye Therapies, LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma and Ocular Hypertension

Intervention: Brimonidine Tartrate 0.025% (Drug); Vehicle (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eye Therapies, LLC


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: IOP


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Clinical Site, Winchester, Massachusetts 01890, United States
Additional Information

Starting date: September 2012
Last updated: December 21, 2012

Page last updated: August 20, 2015

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