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The Effect of Brimonidine

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ClinicalTrials.gov Identifier: NCT03959176
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date June 27, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Intraocular Pressure [ Time Frame: Baseline (Pre drop administration) ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
  • Intraocular Pressure [ Time Frame: 15 minutes post drop administration ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
  • Intraocular Pressure [ Time Frame: 30 minutes post drop administration ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
  • Intraocular Pressure [ Time Frame: 1 hour post drop administration ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
  • Intraocular Pressure [ Time Frame: 2 hour post drop administration ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
  • Intraocular Pressure [ Time Frame: 4 hour post drop administration ]
    To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Pupil Size [ Time Frame: Baseline (Pre drop administration) ]
    Pupil size measurement
  • Pupil Size [ Time Frame: 15 minutes post drop administration ]
    Pupil size measurement.
  • Pupil Size [ Time Frame: 30 minutes post drop administration ]
    Pupil size measurement
  • Pupil Size [ Time Frame: 1 hour post drop administration ]
    Pupil size measurement.
  • Pupil Size [ Time Frame: 2 hours post drop administration, 4 hours post drop administration ]
    Pupil size measurement.
  • Pupil Size [ Time Frame: 4 hours post drop administration ]
    Pupil size measurement
  • Pupil Reaction to Light [ Time Frame: Baseline (Pre drop administration) ]
    Pupil reaction to light will be measured as none, poor or brisk.
  • Pupil Reaction to Light [ Time Frame: 15 minutes post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.
  • Pupil Reaction to Light [ Time Frame: 30 minutes post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.
  • Pupil Reaction to Light [ Time Frame: 1 hour post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.
  • Pupil Reaction to Light [ Time Frame: 2 hours post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.
  • Pupil Reaction to Light [ Time Frame: 4 hours post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Brimonidine
Official Title  ICMJE The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
Brief Summary This study will evaluate whether pre-treating patients with Brimonidine 0.2% before and/or after dilating the pupils will help to control the changes in intraocular pressure often seen when using dilating drops. The study will also evaluate the effects of different sequences of administering dilating drops along with Brimonidine on pupil size and reactivity.
Detailed Description Intraocular pressure (IOP) can fluctuate due to various external factors such as exercise, medications, and eye movements. Although it is considered natural for IOP to fluctuate daily, prolonged increases in IOP can be harmful. Sustained elevated IOP has been linked to optic nerve damage and glaucoma. Mydriatic drops routinely given to dilate pupils in patients in need of an eye exam have been known to increase IOP. In practice, a combination of drugs are used to achieve pupil dilation needed for routine eye exams or in perioperative situations. The use of Tropicamide 1% and Phenylephrine 2.5% are known to be safe and effective options for dilating the pupils when used in conjunction with one another, but these drugs can increase IOP. Drugs such as Brimonidine, a selective alpha-2 agonist, are known to reduce IOP through several different methods. This study seeks to understand the effects of Brimonidine used along with Tropicamide and Phenylephrine to control IOP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Intraocular Pressure
Intervention  ICMJE
  • Drug: Brimonidine
    2 drops administered once in the left eye in both study arms
    Other Names:
    • Alphagan
    • Mirvaso
  • Drug: Tropicamide
    1 drop administered at two different times points in both eyes in both study arms
    Other Name: Mydriacyl
  • Drug: Phenylephrine Ophthalmic Product
    1 drop administered at two different time points in both eyes in both study arms
Study Arms  ICMJE
  • Experimental: Group 1

    The right eye will receive a sham drop followed by 1 drop of Tropicamide 1%/Phenylephrine 2.5% five minutes after the sham drop is administered. A one minute wait will occur followed by a second drop of Tropicamide 1%/Phenylephrine 2.5%.

    The left eye will receive 2 drops of Brimonidine 0.2% followed by a five minute wait time. One drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a one minute wait time. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered.

    Interventions:
    • Drug: Brimonidine
    • Drug: Tropicamide
    • Drug: Phenylephrine Ophthalmic Product
  • Experimental: Group 2

    The right eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will be administered followed by a 15 second wait after which a sham drop will be administered.

    The left eye will receive 1 drop of Tropicamide 1%/Phenylephrine 2.5% followed by a one minute wait. A second drop of Tropicamide 1%/Phenylephrine 2.5% will then be administered followed by a 15 second wait after which 2 drops of Brimonidine will be administered.

    Interventions:
    • Drug: Brimonidine
    • Drug: Tropicamide
    • Drug: Phenylephrine Ophthalmic Product
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy individuals
  • Females of childbearing potential must agree to use a reliable method of birth control while participating in the study.

Exclusion Criteria:

  • Diabetic
  • Have a history of glaucoma
  • Have a history of iris trauma
  • Have a history of eye surgery except for LASIK or PRK
  • Pregnant
  • Anisocoria (unequal pupils)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Blair Gordy 336-716-3937 bgordy@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959176
Other Study ID Numbers  ICMJE IRB00058366
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Overall results will be shared, but individual participant data will not be available.
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Keith Walter, MD Wake Forest Baptist Medical Center
PRS Account Wake Forest University Health Sciences
Verification Date June 2019

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