Clinical trial NCT01345448: Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
Official title: Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glaucoma
Keywords: Glaucoma
Brimonidine
Transdermal
Lead sponsor: Nanduri, Padma, M.D., FACS
Sponsor class: INDIV
First posted: 2011-05-02
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular Pressure
timeFrame: Day one, every hour for twelve hours.
measure: Heart Rate
timeFrame: Day one, every hour for twelve hours.
measure: Blood Pressure
timeFrame: Day one, every hour for twelve hours.
measure: Intraocular Pressure
timeFrame: Day two twice, once in the AM, once in the PM.
measure: Intraocular Pressure
timeFrame: Day seven, once.
measure: Intraocular Pressure
timeFrame: Day fourteen, once.
measure: Intraocular Pressure
timeFrame: Day twenty one, once.
measure: Intraocular Pressure
timeFrame: Day twenty eight, once.
measure: Heart Rate
timeFrame: Day two twice, once in the AM, once in the PM.
measure: Heart Rate
timeFrame: Day seven, once.
measure: Heart Rate
timeFrame: Day fourteen, once.
measure: Heart Rate
timeFrame: Day twenty one, once.
measure: Heart Rate
timeFrame: Day twenty eight, once.
measure: Blood Pressure
timeFrame: Day two twice, once in the AM, once in the PM.
measure: Blood Pressure
timeFrame: Day seven, once.
measure: Blood Pressure
timeFrame: Day fourteen, once.
measure: Blood Pressure
timeFrame: Day twenty one, once.
measure: Blood Pressure
timeFrame: Day twenty eight, once.
Secondary outcomes:
Other outcomes:
Locations:
city: Visalia
country: United States
facility: Eye Surgical and Medical Associates
state: California
Study officials:
name: Padma Nanduri, MD
role: PRINCIPAL_INVESTIGATOR
name: Michael Boone, MD
role: STUDY_DIRECTOR
References: