The Effect of Brimonidine

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraocular Pressure

Intervention / Treatment
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* Drug: Brimonidine
* Drug: Tropicamide
* Drug: Phenylephrine Ophthalmic Product


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Drug: Brimonidine<br>* 2 drops administered once in the left eye in both study arms<br>* Other names: Mirvaso;Drug: Tropicamide<br>* 1 drop administered at two different times points in both eyes in both study arms<br>* Other names: Mydriacyl;Drug: Phenylephrine Ophthalmic Product<br>* 1 drop administered at two different time points in both eyes in both study arms<br>|
| Experimental: Group 2<br>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. | Drug: Brimonidine<br>* 2 drops administered once in the left eye in both study arms<br>* Other names: Mirvaso;Drug: Tropicamide<br>* 1 drop administered at two different times points in both eyes in both study arms<br>* Other names: Mydriacyl;Drug: Phenylephrine Ophthalmic Product<br>* 1 drop administered at two different time points in both eyes in both study arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil Size | Pupil size measurement | Baseline (Pre drop administration) | 
| Pupil Size | Pupil size measurement. | 15 minutes post drop administration | 
| Pupil Size | Pupil size measurement | 30 minutes post drop administration | 
| Pupil Size | Pupil size measurement. | 1 hour post drop administration | 
| Pupil Size | Pupil size measurement. | 2 hours post drop administration, 4 hours post drop administration | 
| Pupil Size | Pupil size measurement | 4 hours post drop administration | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | Baseline (Pre drop administration) | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | 15 minutes post drop administration | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | 30 minutes post drop administration | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | 1 hour post drop administration | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | 2 hours post drop administration | 
| Pupil Reaction to Light | Pupil reaction to light will be measured as none, poor or brisk. | 4 hours post drop administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brimonidine, Pupil Effects