NCT03959176

The Effect of Brimonidine

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Brimonidine	2 drops administered once in the left eye in both study arms
DRUG	Tropicamide	1 drop administered at two different times points in both eyes in both study arms
DRUG	Phenylephrine Ophthalmic Product	1 drop administered at two different time points in both eyes in both study arms

Timeline

• Start date: 2019-07-20
• Primary completion: 2019-07-20
• Completion: 2019-07-20
• First posted: 2019-05-22
• Last updated: 2024-02-01
• Results posted: 2024-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study