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Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345448
Recruitment Status : Unknown
Verified April 2011 by Nanduri, Padma, M.D., FACS.
Recruitment status was:  Recruiting
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Information provided by:
Nanduri, Padma, M.D., FACS

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Brimonidine Drug: Placebo Lotion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
Study Start Date : April 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Intervention Details:
  • Drug: Brimonidine
    0.1% Brimonidine Lotion, dosed once.
    Other Name: Alphagan
  • Drug: Placebo Lotion
    Placebo Lotion dosed once.

Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ]
  2. Heart Rate [ Time Frame: Day one, every hour for twelve hours. ]
  3. Blood Pressure [ Time Frame: Day one, every hour for twelve hours. ]
  4. Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  5. Intraocular Pressure [ Time Frame: Day seven, once. ]
  6. Intraocular Pressure [ Time Frame: Day fourteen, once. ]
  7. Intraocular Pressure [ Time Frame: Day twenty one, once. ]
  8. Intraocular Pressure [ Time Frame: Day twenty eight, once. ]
  9. Heart Rate [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  10. Heart Rate [ Time Frame: Day seven, once. ]
  11. Heart Rate [ Time Frame: Day fourteen, once. ]
  12. Heart Rate [ Time Frame: Day twenty one, once. ]
  13. Heart Rate [ Time Frame: Day twenty eight, once. ]
  14. Blood Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  15. Blood Pressure [ Time Frame: Day seven, once. ]
  16. Blood Pressure [ Time Frame: Day fourteen, once. ]
  17. Blood Pressure [ Time Frame: Day twenty one, once. ]
  18. Blood Pressure [ Time Frame: Day twenty eight, once. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345448

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Contact: Michael Boone, MD (559)627-9393
Contact: Padma Nanduri, MD 858-450-1010 ext 134

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United States, California
Eye Surgical and Medical Associates Recruiting
Visalia, California, United States, 93277
Contact: Michael Boone, MD    559-627-9393   
Contact: Amy Smith    (559)627-9393   
Sub-Investigator: Michael Boone, MD         
Sponsors and Collaborators
Nanduri, Padma, M.D., FACS
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Principal Investigator: Padma Nanduri, MD
Study Director: Michael Boone, MD
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Responsible Party: Padma Nanduri, M.D., F.A.C.S. Identifier: NCT01345448    
Other Study ID Numbers: White Rabbit 2010-0001
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by Nanduri, Padma, M.D., FACS:
Additional relevant MeSH terms:
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Brimonidine Tartrate
Ocular Hypertension
Eye Diseases
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs