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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Clinical Site, Winchester, Massachusetts 01890, United States
Additional Information
Starting date: September 2012
Last updated: December 21, 2012
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