The Effect of Brimonidine
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ClinicalTrials.gov Identifier: NCT03959176 |
Recruitment Status :
Completed
First Posted : May 22, 2019
Last Update Posted : July 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intraocular Pressure | Drug: Brimonidine Drug: Tropicamide Drug: Phenylephrine Ophthalmic Product | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects |
Actual Study Start Date : | July 20, 2019 |
Actual Primary Completion Date : | July 20, 2019 |
Actual Study Completion Date : | July 20, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: 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. |
Drug: Brimonidine
2 drops administered once in the left eye in both study arms
Other Names:
Drug: Tropicamide 1 drop administered at two different times points in both eyes in both study arms
Other Name: Mydriacyl Drug: Phenylephrine Ophthalmic Product 1 drop administered at two different time points in both eyes in both study arms |
Experimental: 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. |
Drug: Brimonidine
2 drops administered once in the left eye in both study arms
Other Names:
Drug: Tropicamide 1 drop administered at two different times points in both eyes in both study arms
Other Name: Mydriacyl Drug: Phenylephrine Ophthalmic Product 1 drop administered at two different time points in both eyes in both study arms |
- Intraocular Pressure [ Time Frame: 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.
- Intraocular Pressure [ Time Frame: 15 minutes post drop administration ]To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
- Intraocular Pressure [ Time Frame: 30 minutes post drop administration ]To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
- Intraocular Pressure [ Time Frame: 1 hour post drop administration ]To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
- Intraocular Pressure [ Time Frame: 2 hour post drop administration ]To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
- Intraocular Pressure [ Time Frame: 4 hour post drop administration ]To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
- Pupil Size [ Time Frame: Baseline (Pre drop administration) ]Pupil size measurement
- Pupil Size [ Time Frame: 15 minutes post drop administration ]Pupil size measurement.
- Pupil Size [ Time Frame: 30 minutes post drop administration ]Pupil size measurement
- Pupil Size [ Time Frame: 1 hour post drop administration ]Pupil size measurement.
- Pupil Size [ Time Frame: 2 hours post drop administration, 4 hours post drop administration ]Pupil size measurement.
- Pupil Size [ Time Frame: 4 hours post drop administration ]Pupil size measurement
- Pupil Reaction to Light [ Time Frame: Baseline (Pre drop administration) ]Pupil reaction to light will be measured as none, poor or brisk.
- Pupil Reaction to Light [ Time Frame: 15 minutes post drop administration ]Pupil reaction to light will be measured as none, poor or brisk.
- Pupil Reaction to Light [ Time Frame: 30 minutes post drop administration ]Pupil reaction to light will be measured as none, poor or brisk.
- Pupil Reaction to Light [ Time Frame: 1 hour post drop administration ]Pupil reaction to light will be measured as none, poor or brisk.
- Pupil Reaction to Light [ Time Frame: 2 hours post drop administration ]Pupil reaction to light will be measured as none, poor or brisk.
- Pupil Reaction to Light [ Time Frame: 4 hours post drop administration ]Pupil reaction to light will be measured as none, poor or brisk.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959176
United States, North Carolina | |
Wake Forest Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Keith Walter, MD | Wake Forest Baptist Medical Center |
Documents provided by Wake Forest University Health Sciences:
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT03959176 |
Other Study ID Numbers: |
IRB00058366 |
First Posted: | May 22, 2019 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Overall results will be shared, but individual participant data will not be available. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Brimonidine Pupil Effects |
Brimonidine Tartrate Phenylephrine Oxymetazoline Tropicamide Cardiotonic Agents Mydriatics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents |
Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |