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The Effect of Brimonidine

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ClinicalTrials.gov Identifier: NCT03959176
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: Brimonidine Drug: Tropicamide Drug: Phenylephrine Ophthalmic Product Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
Actual Study Start Date : July 20, 2019
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Pupil Size [ Time Frame: Baseline (Pre drop administration) ]
    Pupil size measurement

  2. Pupil Size [ Time Frame: 15 minutes post drop administration ]
    Pupil size measurement.

  3. Pupil Size [ Time Frame: 30 minutes post drop administration ]
    Pupil size measurement

  4. Pupil Size [ Time Frame: 1 hour post drop administration ]
    Pupil size measurement.

  5. Pupil Size [ Time Frame: 2 hours post drop administration, 4 hours post drop administration ]
    Pupil size measurement.

  6. Pupil Size [ Time Frame: 4 hours post drop administration ]
    Pupil size measurement

  7. Pupil Reaction to Light [ Time Frame: Baseline (Pre drop administration) ]
    Pupil reaction to light will be measured as none, poor or brisk.

  8. Pupil Reaction to Light [ Time Frame: 15 minutes post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.

  9. Pupil Reaction to Light [ Time Frame: 30 minutes post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.

  10. Pupil Reaction to Light [ Time Frame: 1 hour post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.

  11. Pupil Reaction to Light [ Time Frame: 2 hours post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.

  12. Pupil Reaction to Light [ Time Frame: 4 hours post drop administration ]
    Pupil reaction to light will be measured as none, poor or brisk.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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 ClinicalTrials.gov identifier (NCT number): NCT03959176


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Keith Walter, MD Wake Forest Baptist Medical Center

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03959176     History of Changes
Other Study ID Numbers: IRB00058366
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Overall results will be shared, but individual participant data will not be available.

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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
Keywords provided by Wake Forest University Health Sciences:
Brimonidine
Pupil Effects
Additional relevant MeSH terms:
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Brimonidine Tartrate
Phenylephrine
Oxymetazoline
Tropicamide
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents