Intraocular PressurePhase 4NCT03959176
The Effect of Brimonidine
A Phase 4 study testing Brimonidine, Tropicamide and Phenylephrine Ophthalmic Product in people with Intraocular Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Brimonidine, Tropicamide and Phenylephrine Ophthalmic Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2019to 20 Jul 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Females of childbearing potential must agree to use a reliable method of birth control while participating in the study.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
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.
Read the 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.
- Conditions
- Intraocular Pressure
- Being tested
- Brimonidine, Tropicamide, Phenylephrine Ophthalmic Product
- Keywords
- Brimonidine, Pupil Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrimonidineDrug
Also called Alphagan, Mirvaso
2 drops administered once in the left eye in both study arms
TropicamideDrug
Also called Mydriacyl
1 drop administered at two different times points in both eyes in both study arms
Phenylephrine Ophthalmic ProductDrug
1 drop administered at two different time points in both eyes in both study arms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Brimonidine; Drug: Tropicamide; Drug: Phenylephrine Ophthalmic Product |
| 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. Receives: Drug: Brimonidine; Drug: Tropicamide; Drug: Phenylephrine Ophthalmic Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
To observe how differing the sequence of administration of Tropicamide 1%/Phenylephrine 2.5% and Brimonidine 0.2% influences intraocular pressure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hour post drop administration
Secondary outcomes (12)
Pupil Size
Pupil size measurement
Measured: Baseline (Pre drop administration)
Pupil Size
Pupil size measurement.
Measured: 15 minutes post drop administration
Pupil Size
Pupil size measurement
Measured: 30 minutes post drop administration
Pupil Size
Pupil size measurement.
Measured: 1 hour post drop administration
Pupil Size
Pupil size measurement.
Measured: 2 hours post drop administration
Pupil Size
Pupil size measurement
Measured: 4 hours post drop administration
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: Baseline (Pre drop administration)
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: 15 minutes post drop administration
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: 30 minutes post drop administration
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: 1 hour post drop administration
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: 2 hours post drop administration
Pupil Reaction to Light
Pupil reaction to light will be measured as none (0), poor (1) or brisk (2).
Measured: 4 hours post drop administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start20 Jul 2019
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Walter, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959176
- Sponsor's protocol ID
- IRB00058366
- Status last verified
- Jul 2020
- First submitted
- 20 May 2019
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Overall results will be shared, but individual participant data will not be available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients, Pressure Control and Pupil Effects
- ClinicalTrials.gov ID
- NCT03959176
- Acronym / sponsor ID
- IRB00058366
- Conditions
- Intraocular Pressure
- Keywords
- Brimonidine, Pupil Effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Brimonidine, Drug: Tropicamide, Drug: Phenylephrine Ophthalmic ProductThe 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. |
| Group 2 | Experimental | Drug: Brimonidine, Drug: Tropicamide, Drug: Phenylephrine Ophthalmic ProductThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Females of childbearing potential must agree to use a reliable method of birth control while participating in the study.
Key exclusion criteria (6 listed)
- Diabetic
- Have a history of glaucoma
- Have a history of iris trauma
- Have a history of eye surgery except for LASIK or PRK
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrimonidineAlso: Alphagan, Mirvaso2 drops administered once in the left eye in both study arms | Drug | Group 1, Group 2 |
| TropicamideAlso: Mydriacyl1 drop administered at two different times points in both eyes in both study arms | Drug | Group 1, Group 2 |
| Phenylephrine Ophthalmic Product1 drop administered at two different time points in both eyes in both study arms | Drug | Group 1, Group 2 |
Primary outcome
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.
12 secondary outcomes
Pupil Size
Time frame: Baseline (Pre drop administration)
Pupil Size
Time frame: 15 minutes post drop administration
Pupil Size
Time frame: 30 minutes post drop administration
Pupil Size
Time frame: 1 hour post drop administration
Pupil Size
Time frame: 2 hours post drop administration
Pupil Size
Time frame: 4 hours post drop administration
Pupil Reaction to Light
Time frame: Baseline (Pre drop administration)
Pupil Reaction to Light
Time frame: 15 minutes post drop administration
Pupil Reaction to Light
Time frame: 30 minutes post drop administration
Pupil Reaction to Light
Time frame: 1 hour post drop administration
Pupil Reaction to Light
Time frame: 2 hours post drop administration
Pupil Reaction to Light
Time frame: 4 hours post drop administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Overall results will be shared, but individual participant data will not be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Walter, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine, Tropicamide and Phenylephrine Ophthalmic Product in people with Intraocular Pressure, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: Baseline (Pre drop administration)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.