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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma and Ocular Hypertension
• Intervention / Treatment: Drug: Brimonidine Tartrate 0.025%; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Brimonidine Tartrate 0.025%; 1 drop in each eye daily four times a day for 14 days; Drug: Vehicle; 1 drop in each eye daily four times a day for 14 days
Active Comparator: Brimonidine Tartrate 0.025%	Drug: Brimonidine Tartrate 0.025%; 1 drop in each eye daily four times a day for 14 days; Drug: Vehicle; 1 drop in each eye daily four times a day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IOP	14 days

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety	For up to 8 weeks

Collaborators and Investigators

• Sponsor: Eye Therapies, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 25, 2012
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 12-150-0001