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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

Information source: Nanduri, Padma, M.D., FACS
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Brimonidine (Drug); Placebo Lotion (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Nanduri, Padma, M.D., FACS

Official(s) and/or principal investigator(s):
Padma Nanduri, MD, Principal Investigator
Michael Boone, MD, Study Director

Overall contact:
Michael Boone, MD, Phone: (559)627-9393, Email: drboone@visaliaeyecare.com


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.

Clinical Details

Official title: Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Intraocular Pressure

Heart Rate

Blood Pressure

Intraocular Pressure

Intraocular Pressure

Intraocular Pressure

Intraocular Pressure

Intraocular Pressure

Heart Rate

Heart Rate

Heart Rate

Heart Rate

Heart Rate

Blood Pressure

Blood Pressure

Blood Pressure

Blood Pressure

Blood Pressure

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.


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Michael Boone, MD, Phone: (559)627-9393, Email: drboone@visaliaeyecare.com

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

Starting date: April 2011
Last updated: April 28, 2011

Page last updated: August 20, 2015

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