Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Brimonidine; Drug: Placebo Lotion

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Visalia, California, United States, 93277
      • Recruiting
      • Eye Surgical and Medical Associates
      • Contact: Michael Boone, MD; Phone Number: 559-627-9393; Email: drboone@visaliaeyecare.com
      • Contact: Amy Smith; Phone Number: (559)627-9393; Email: amys@visaliaeyecare.com
      • Sub-Investigator: Michael Boone, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
• Male or Female patients aged at least 18 years of age.
• Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
• A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
• Best-Corrected Visual Acuity of 20/800 or better in both eyes
• Written informed consent.
• Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

• Uncontrolled glaucoma
• Glaucoma requiring more than a single agent for IOP control
• Patients with a corneal thickness greater then 620 micrometers
• Female patients who are pregnant, nursing, or planning a pregnancy during the study
• Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
• Uncontrolled or labile hypertension
• At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular Pressure	Day one, every hour for twelve hours.
Heart Rate	Day one, every hour for twelve hours.
Blood Pressure	Day one, every hour for twelve hours.
Intraocular Pressure	Day two twice, once in the AM, once in the PM.
Intraocular Pressure	Day seven, once.
Intraocular Pressure	Day fourteen, once.
Intraocular Pressure	Day twenty one, once.
Intraocular Pressure	Day twenty eight, once.
Heart Rate	Day two twice, once in the AM, once in the PM.
Heart Rate	Day seven, once.
Heart Rate	Day fourteen, once.
Heart Rate	Day twenty one, once.
Heart Rate	Day twenty eight, once.
Blood Pressure	Day two twice, once in the AM, once in the PM.
Blood Pressure	Day seven, once.
Blood Pressure	Day fourteen, once.
Blood Pressure	Day twenty one, once.
Blood Pressure	Day twenty eight, once.

Collaborators and Investigators

• Sponsor: Nanduri, Padma, M.D., FACS
• Investigators: Principal Investigator: Padma Nanduri, MD; Study Director: Michael Boone, MD

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): May 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 28, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Transdermal; Glaucoma; Brimonidine
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; 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: White Rabbit 2010-0001