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

Eye Therapies, LLC1 site in 1 country15 target enrollmentSeptember 2012

ConditionsGlaucoma and Ocular Hypertension

InterventionsBrimonidine Tartrate 0.025%Vehicle

DrugsBrimonidine Tartrate 0.025%Vehicle

Overview

Phase: Phase 1
Intervention: Brimonidine Tartrate 0.025%
Conditions: Glaucoma and Ocular Hypertension
Sponsor: Eye Therapies, LLC
Enrollment: 15
Locations: 1
Primary Endpoint: IOP
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Eye Therapies, LLC

Responsible Party

Sponsor

Eligibility Criteria

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.