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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
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| Group 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine | Drug | 2 drops administered once in the left eye in both study arms |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil Size | Pupil size measurement | Baseline (Pre drop administration) |
| Pupil Size | Pupil size measurement. | 15 minutes post drop administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Walter, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
Overall results will be shared, but individual participant data will not be available.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Eye Exam |
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| Opposite Eye Exam |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Pre drop administration) | Eyes | Eyes |
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baseline through hour 4
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Right Eye | 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%. 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith Walter, MD | Wake Forest University School of Medicine | 336-716-2144 | kwalter@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2019 | Oct 12, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2019 | May 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Tropicamide | Drug | 1 drop administered at two different times points in both eyes in both study arms |
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| Phenylephrine Ophthalmic Product | Drug | 1 drop administered at two different time points in both eyes in both study arms |
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| 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 |
| Pupil Size | Pupil size measurement | 4 hours post drop administration |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Baseline (Pre drop administration) |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | 15 minutes post drop administration |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | 30 minutes post drop administration |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | 1 hour post drop administration |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | 2 hours post drop administration |
| Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | 4 hours post drop administration |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 Tropicamide: 1 drop administered at two different times points in both left and right eyes Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both left and right eyes |
| OG002 | Group 2 Right Eye | 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. Tropicamide: 1 drop administered at two different times points in both the left and right eyes. Phenylephrine Ophthalmic Product: 1 drop administered at two different time points in both the left and right eyes. |
| OG003 | Group 2 Left Eye | 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 Tropicamide: 1 drop administered at two different times points in both the left and right eyes. Phenylephrine Ophthalmic Product: 1 drop administered at two different time points both the left and right eyes. |
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| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | mmHg | 15 minutes post drop administration | Eyes | Eyes |
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| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | mmHg | 30 minutes post drop administration |
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| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | mmHg | 1 hour post drop administration | Eyes | Eyes |
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| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | mmHg | 2 hour post drop administration | Eyes | Eyes |
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| Primary | Intraocular Pressure | To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure. | Posted | Mean | Standard Deviation | mmHg | 4 hour post drop administration | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline (Pre drop administration) | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement. | Posted | Mean | Standard Deviation | mm | 15 minutes post drop administration | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement | Posted | Mean | Standard Deviation | mm | 30 minutes post drop administration | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement. | Posted | Mean | Standard Deviation | mm | 1 hour post drop administration | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement. | Posted | Mean | Standard Deviation | mm | 2 hours post drop administration | Eyes | Eyes |
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| Secondary | Pupil Size | Pupil size measurement | Posted | Mean | Standard Deviation | mm | 4 hours post drop administration | Eyes | Eyes |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Pre drop administration) |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes post drop administration |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes post drop administration |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | 1 hour post drop administration |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | 2 hours post drop administration |
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| Secondary | Pupil Reaction to Light | Pupil reaction to light will be measured as none (0), poor (1) or brisk (2). | Data only collected for Right Eye in each group. | Posted | Mean | Standard Deviation | score on a scale | 4 hours post drop administration |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Group 1 Left Eye | 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 | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Group 2 Right Eye | 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. 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Group 2 Left Eye | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | All Group 1 Participants | The whole participant including all body systems. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG005 | All Group 2 Participants | The whole participant including all body systems. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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