The Effect of Brimonidine

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Principal Investigator: Keith Walter, MD; Wake Forest Baptist Medical Center

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03959176
• Other Study ID Numbers: IRB00058366
• First Posted: May 22, 2019
• 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.

• 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:

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