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