The Effect of Brimonidine

Intraocular Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959176
• Other study ID #: IRB00058366
• Status: Completed
• Phase: Phase 4
• Start date: July 20, 2019
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• Brimonidine
2 drops administered once in the left eye in both study arms
• Tropicamide
1 drop administered at two different times points in both eyes in both study arms
• Phenylephrine Ophthalmic Product
1 drop administered at two different time points in both eyes in both study arms

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

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