Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Nanduri, Padma, M.D., FACS.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nanduri, Padma, M.D., FACS
ClinicalTrials.gov Identifier:
NCT01345448
First received: April 27, 2011
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Glaucoma
Drug: Brimonidine
Drug: Placebo Lotion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy

Resource links provided by NLM:


Further study details as provided by Nanduri, Padma, M.D., FACS:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ] [ Designated as safety issue: No ]
  • Heart Rate [ Time Frame: Day one, every hour for twelve hours. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day one, every hour for twelve hours. ] [ Designated as safety issue: Yes ]
  • Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ] [ Designated as safety issue: No ]
  • Intraocular Pressure [ Time Frame: Day seven, once. ] [ Designated as safety issue: No ]
  • Intraocular Pressure [ Time Frame: Day fourteen, once. ] [ Designated as safety issue: No ]
  • Intraocular Pressure [ Time Frame: Day twenty one, once. ] [ Designated as safety issue: No ]
  • Intraocular Pressure [ Time Frame: Day twenty eight, once. ] [ Designated as safety issue: No ]
  • Heart Rate [ Time Frame: Day two twice, once in the AM, once in the PM. ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Day seven, once. ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Day fourteen, once. ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Day twenty one, once. ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: Day twenty eight, once. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day seven, once. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day fourteen, once. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day twenty one, once. ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Day twenty eight, once. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: April 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Brimonidine
    0.1% Brimonidine Lotion, dosed once.
    Other Name: Alphagan
    Drug: Placebo Lotion
    Placebo Lotion dosed once.
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345448

Contacts
Contact: Michael Boone, MD (559)627-9393 drboone@visaliaeyecare.com
Contact: Padma Nanduri, MD 858-450-1010 ext 134 drnanduri@envisioneye.com

Locations
United States, California
Eye Surgical and Medical Associates Recruiting
Visalia, California, United States, 93277
Contact: Michael Boone, MD    559-627-9393    drboone@visaliaeyecare.com   
Contact: Amy Smith    (559)627-9393    amys@visaliaeyecare.com   
Sub-Investigator: Michael Boone, MD         
Sponsors and Collaborators
Nanduri, Padma, M.D., FACS
Investigators
Principal Investigator: Padma Nanduri, MD
Study Director: Michael Boone, MD
  More Information

No publications provided

Responsible Party: Padma Nanduri, M.D., F.A.C.S.
ClinicalTrials.gov Identifier: NCT01345448     History of Changes
Other Study ID Numbers: White Rabbit 2010-0001
Study First Received: April 27, 2011
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nanduri, Padma, M.D., FACS:
Glaucoma
Brimonidine
Transdermal

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Brimonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014