The Effect of Brimonidine

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03959176

Enrollment

Registered

2019-05-22

Start date

2019-07-20

Completion date

2019-07-20

Last updated

2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Keywords

Brimonidine, Pupil Effects

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.

Interventions

DRUGBrimonidine

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

DRUGTropicamide

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

DRUGPhenylephrine Ophthalmic Product

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Intraocular Pressure	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.

Secondary

Measure	Time frame	Description
Pupil Size	Baseline (Pre drop administration)	Pupil size measurement
Pupil Reaction to Light	Baseline (Pre drop administration)	Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. 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	7
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. 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	6
Total	13

Baseline characteristics

Characteristic	Group 1	Total	Group 2
Age, Continuous	22.8 years STANDARD_DEVIATION 0.7	23.25 years STANDARD_DEVIATION 0.64	23.7 years STANDARD_DEVIATION 1.5
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	7 Participants	13 Participants	6 Participants
Region of Enrollment United States	7 participants	13 participants	6 participants
Sex: Female, Male Female	4 Participants	6 Participants	2 Participants
Sex: Female, Male Male	3 Participants	7 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 7	0 / 6	0 / 6	0 / 7	0 / 6
other Total, other adverse events	0 / 7	0 / 7	0 / 6	0 / 6	0 / 7	0 / 6
serious Total, serious adverse events	0 / 7	0 / 7	0 / 6	0 / 6	0 / 7	0 / 6

Outcome results

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: Baseline (Pre drop administration)

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	15.4 millimeters of mercury (mmHg)	Standard Deviation 2.4
Group 1 Left Eye	Intraocular Pressure	16.3 millimeters of mercury (mmHg)	Standard Deviation 2.4
Group 2 Right Eye	Intraocular Pressure	16.5 millimeters of mercury (mmHg)	Standard Deviation 1.5
Group 2 Left Eye	Intraocular Pressure	16.7 millimeters of mercury (mmHg)	Standard Deviation 1.3

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: 15 minutes post drop administration

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	15.3 mmHg	Standard Deviation 2
Group 1 Left Eye	Intraocular Pressure	13.1 mmHg	Standard Deviation 1.5
Group 2 Right Eye	Intraocular Pressure	13.5 mmHg	Standard Deviation 1.7
Group 2 Left Eye	Intraocular Pressure	15.0 mmHg	Standard Deviation 1.2

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: 30 minutes post drop administration

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	14.6 mmHg	Standard Deviation 1.7
Group 1 Left Eye	Intraocular Pressure	12.3 mmHg	Standard Deviation 1.5
Group 2 Right Eye	Intraocular Pressure	14.3 mmHg	Standard Deviation 1.8
Group 2 Left Eye	Intraocular Pressure	14.8 mmHg	Standard Deviation 1.4

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: 1 hour post drop administration

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	15.1 mmHg	Standard Deviation 2
Group 1 Left Eye	Intraocular Pressure	12.4 mmHg	Standard Deviation 1.8
Group 2 Right Eye	Intraocular Pressure	13.5 mmHg	Standard Deviation 2
Group 2 Left Eye	Intraocular Pressure	13.2 mmHg	Standard Deviation 1.9

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: 2 hour post drop administration

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	14.3 mmHg	Standard Deviation 1.7
Group 1 Left Eye	Intraocular Pressure	11.9 mmHg	Standard Deviation 1.4
Group 2 Right Eye	Intraocular Pressure	12.7 mmHg	Standard Deviation 1
Group 2 Left Eye	Intraocular Pressure	14.2 mmHg	Standard Deviation 1.3

Primary

Intraocular Pressure

To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.

Time frame: 4 hour post drop administration

Arm	Measure	Value (MEAN)	Dispersion
Group 1 Right Eye	Intraocular Pressure	12.4 mmHg	Standard Deviation 1.7
Group 1 Left Eye	Intraocular Pressure	9.3 mmHg	Standard Deviation 1.3
Group 2 Right Eye	Intraocular Pressure	11.0 mmHg	Standard Deviation 1.2
Group 2 Left Eye	Intraocular Pressure	13.7 mmHg	Standard Deviation 1.8

Secondary