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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.
 
ClinicalTrials.gov 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
Sponsor:
Information provided by:
Nanduri, Padma, M.D., FACS

Tracking Information
First Submitted Date  ICMJE April 27, 2011
First Posted Date  ICMJE May 2, 2011
Last Update Posted Date May 2, 2011
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
  • Intraocular Pressure [ Time Frame: Day one, every hour for twelve hours. ]
  • Heart Rate [ Time Frame: Day one, every hour for twelve hours. ]
  • Blood Pressure [ Time Frame: Day one, every hour for twelve hours. ]
  • Intraocular Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  • Intraocular Pressure [ Time Frame: Day seven, once. ]
  • Intraocular Pressure [ Time Frame: Day fourteen, once. ]
  • Intraocular Pressure [ Time Frame: Day twenty one, once. ]
  • Intraocular Pressure [ Time Frame: Day twenty eight, once. ]
  • Heart Rate [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  • Heart Rate [ Time Frame: Day seven, once. ]
  • Heart Rate [ Time Frame: Day fourteen, once. ]
  • Heart Rate [ Time Frame: Day twenty one, once. ]
  • Heart Rate [ Time Frame: Day twenty eight, once. ]
  • Blood Pressure [ Time Frame: Day two twice, once in the AM, once in the PM. ]
  • Blood Pressure [ Time Frame: Day seven, once. ]
  • Blood Pressure [ Time Frame: Day fourteen, once. ]
  • Blood Pressure [ Time Frame: Day twenty one, once. ]
  • Blood Pressure [ Time Frame: Day twenty eight, once. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy
Official Title  ICMJE Study of Safety and IOP Lowering Efficacy of Transdermal Brimonidine Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Drug: Brimonidine
    0.1% Brimonidine Lotion, dosed once.
    Other Name: Alphagan
  • Drug: Placebo Lotion
    Placebo Lotion dosed once.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01345448
Other Study ID Numbers  ICMJE White Rabbit 2010-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Padma Nanduri, M.D., F.A.C.S.
Study Sponsor  ICMJE Nanduri, Padma, M.D., FACS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Padma Nanduri, MD
Study Director: Michael Boone, MD
PRS Account Nanduri, Padma, M.D., FACS
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP