The Effect of Brimonidine

NCT ID: NCT03959176

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2019-07-20

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.

Conditions

Intraocular Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Brimonidine

Intervention Type: DRUG

2 drops administered once in the left eye in both study arms

Tropicamide

Intervention Type: DRUG

1 drop administered at two different times points in both eyes in both study arms

Phenylephrine Ophthalmic Product

Intervention Type: DRUG

1 drop administered at two different time points in both eyes in both study arms

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.

Group Type: EXPERIMENTAL

Brimonidine

Intervention Type: DRUG

2 drops administered once in the left eye in both study arms

Tropicamide

Intervention Type: DRUG

1 drop administered at two different times points in both eyes in both study arms

Phenylephrine Ophthalmic Product

Intervention Type: DRUG

1 drop administered at two different time points in both eyes in both study arms

Interventions

Brimonidine

2 drops administered once in the left eye in both study arms

Intervention Type: DRUG

Tropicamide

1 drop administered at two different times points in both eyes in both study arms

Intervention Type: DRUG

Phenylephrine Ophthalmic Product

1 drop administered at two different time points in both eyes in both study arms

Intervention Type: DRUG

Other Intervention Names

Alphagan; Mirvaso; Mydriacyl

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Walter, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00058366

Identifier Type: -

Identifier Source: org_study_id