The Effect of Brimonidine

The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure
• Intervention / Treatment: Drug: Brimonidine; Drug: Tropicamide; Drug: Phenylephrine Ophthalmic Product

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: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Mirvaso; Alphagan; Drug: Tropicamide; 1 drop administered at two different times points in both eyes in both study arms; Other Names: 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: Mirvaso; Alphagan; Drug: Tropicamide; 1 drop administered at two different times points in both eyes in both study arms; Other Names: Mydriacyl; Drug: Phenylephrine Ophthalmic Product; 1 drop administered at two different time points in both eyes in both study arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	Baseline (Pre drop administration)
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	15 minutes post drop administration
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	30 minutes post drop administration
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	1 hour post drop administration
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	2 hour post drop administration
Intraocular Pressure	To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.	4 hour post drop administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupil Size	Pupil size measurement	Baseline (Pre drop administration)
Pupil Size	Pupil size measurement.	15 minutes post drop administration
Pupil Size	Pupil size measurement	30 minutes post drop administration
Pupil Size	Pupil size measurement.	1 hour post drop administration
Pupil Size	Pupil size measurement	4 hours post drop administration
Pupil Size	Pupil size measurement.	2 hours post drop administration
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	Baseline (Pre drop administration)
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	15 minutes post drop administration
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	30 minutes post drop administration
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	1 hour post drop administration
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	2 hours post drop administration
Pupil Reaction to Light	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).	4 hours post drop administration

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Keith Walter, MD, Wake Forest Baptist Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2019
• Primary Completion (Actual): July 20, 2019
• Study Completion (Actual): July 20, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Brimonidine; Pupil Effects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Brimonidine Tartrate; Phenylephrine; Oxymetazoline; Tropicamide
• Other Study ID Numbers: IRB00058366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Overall results will be shared, but individual participant data will not be available.

Drug and device information, study documents

• 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