Clinical trial NCT03959176: The Effect of Brimonidine
Official title: The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraocular Pressure
Keywords: Brimonidine
Pupil Effects
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Intraocular Pressure
timeFrame: Baseline (Pre drop administration)
measure: Intraocular Pressure
timeFrame: 15 minutes post drop administration
measure: Intraocular Pressure
timeFrame: 30 minutes post drop administration
measure: Intraocular Pressure
timeFrame: 1 hour post drop administration
measure: Intraocular Pressure
timeFrame: 2 hour post drop administration
measure: Intraocular Pressure
timeFrame: 4 hour post drop administration
Secondary outcomes:
measure: Pupil Size
timeFrame: Baseline (Pre drop administration)
measure: Pupil Size
timeFrame: 15 minutes post drop administration
measure: Pupil Size
timeFrame: 30 minutes post drop administration
measure: Pupil Size
timeFrame: 1 hour post drop administration
measure: Pupil Size
timeFrame: 2 hours post drop administration
measure: Pupil Size
timeFrame: 4 hours post drop administration
measure: Pupil Reaction to Light
timeFrame: Baseline (Pre drop administration)
measure: Pupil Reaction to Light
timeFrame: 15 minutes post drop administration
measure: Pupil Reaction to Light
timeFrame: 30 minutes post drop administration
measure: Pupil Reaction to Light
timeFrame: 1 hour post drop administration
measure: Pupil Reaction to Light
timeFrame: 2 hours post drop administration
measure: Pupil Reaction to Light
timeFrame: 4 hours post drop administration
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Keith Walter, MD
role: PRINCIPAL_INVESTIGATOR
References: