Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

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.

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.