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

Phase 1

Completed

• Conditions: Glaucoma and Ocular Hypertension
• Interventions: Drug: Brimonidine Tartrate 0.025%; Drug: Vehicle

• Registration Number: NCT01687426
• Lead Sponsor: Eye Therapies, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Brimonidine Tartrate 0.025%	Brimonidine Tartrate 0.025%	-
Brimonidine Tartrate 0.025%	Vehicle	-
Vehicle	Brimonidine Tartrate 0.025%	-
Vehicle	Vehicle	-

Primary Outcome Measures

Name	Time	Method
IOP	14 days

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Winchester, Massachusetts, United States