MydriasisPhase 2NCT02946125
Study of the Safety, Efficacy and PK of EYN-1601 in Dilation of the Pupil
A Phase 2 study testing MDD-administered EYN-1601, Phenylephrine 2.5% Eyedrop and Phenylephrine 10% Eyedrop in people with Mydriasis, run by Eyenovia Inc. at 1 site in United States.
Trial summary
This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mydriasis
- What is being tested?
- MDD-administered EYN-1601, Phenylephrine 2.5% Eyedrop and Phenylephrine 10% Eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1.
- Provide signed written consent prior to participation in any study-related procedures
Who cannot join
- Pregnancy or lactation.
- History of diabetes.
- History of cardiac, renal, or hepatic impairment or disease.
- Allergy to phenylephrine hydrochloride.
- Allergy to benzalkonium chloride.
- History of closed-angle glaucoma.
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- Anatomically narrow anterior chamber angles (or Shaffer gonioscopic grade of ≥ 2 in either eye).
- Hypertension or treatment for systemic hypertension.
- Ocular surgery or laser treatment of any kind in the study eye within 3 months.
- History of benign prostatic hyperplasia.
- History of chronic or acute uveitis.
- History of traumatic iritis or hyphema.
- History of traumatic mydriasis or angle recession.
- History of anxiety or panic disorders.
- History of thyrotoxicosis, hypothyroidism, or endocrine disease.
- Use of calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, and systemic steroids (topical, inhaled, intranasal, or perianal steroids are permitted) during the study period.
- Participation in any study of an investigational product or device within 30 days prior to Screening or at any time during the study period.
- Irregularly-shaped pupil secondary to ocular trauma, intraocular surgery or congenital defect.
- History of neurogenic pupil disorder (eg, Horner's syndrome, third cranial nerve palsy, Adie's pupil, Argyl Robertson syndrome, etc.).
- History of anterior chamber intraocular lens (IOL) or iris-fixated IOL.
- History of iris surgery of any kind (eg, iridotomy, iridectomy, coreoplasty)
- History of iris atrophy
- Unwilling to discontinue use of contact lenses on the day of a treatment visit.
- Current active eye disease other than dry eye disease (ie, any disease for which topical or systemic ophthalmic medication is necessary).
- Use of any ophthalmic medication except unpreserved artificial tears on the day of a treatment visit.
- Has a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Observer-Masked, Active-Controlled, Phase 2 Study of the Safety, Efficacy and Pharmacokinetics of EYN-1601 in Dilation of the Pupil
This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.
Read the detailed description
EYN-1601 delivered topically as a microdose via a proprietary delivery system (the Eyenovia Multi-Dose Device [MDD] system) is being investigated for dilation of the pupil for ophthalmic examinations and procedures. Phenylephrine hydrochloride, a sympathetic α1-adrenergic agonist, has been used for pupil dilation for over 70 years. The mydriatic action of phenylephrine is due to its stimulation of the α1 receptors of the radial muscle of the iris, which causes the muscle fibers to contract and results in pupil dilation.
When conducting a variety of ophthalmological procedures, it is necessary to dilate (enlarge) the pupil to allow an unobstructed view of the lens and retina, as well as the optic nerve. The degree of pupil dilation required is somewhat dependent on the procedure being performed. Eyenovia, the Sponsor, is a specialty pharmaceutical company focused on the development of ophthalmic drug products that can be delivered in small volumes, ie, via microdosing, in order to maximize therapeutic control and minimize systemic absorption. To achieve this goal, Eyenovia is developing a drug/device combination product to allow accurate topical ocular delivery of controlled quantities of specific active pharmaceutical ingredients.
Phenylephrine has been known to cause systemic cardiovascular effects in some patients when dosed via the topical ocular route including hypertension, tachycardia, and more rarely, arrhythmia and stroke, especially in those patients with pre-existing heart conditions. These risks are even more relevant when phenylephrine hydrochloride ophthalmic solution 10% is used in circumstances where a greater degree of mydriasis is required. Microdosing with the Eyenovia MDD system is expected to significantly reduce or eliminate these risks while allowing the same degree of mydriasis produced with the currently approved products.
Subjects (healthy volunteers) will be screened for eligibility and 12 subjects that meet inclusion/exclusion criteria will be enrolled into the study. All subjects will be followed through the same pre-specified treatment visit schedule at which the 3 study drugs are administered (phenylephrine 2.5% eyedrops at Visit 1, phenylephrine 10% eyedrops at Visit 2 and EYN-1601 MDD at Visit 3). At each treatment visit, baseline measurements will be taken prior to study medication administration.
Subjects will participate in safety, efficacy, and pharmacokinetic assessments. Subsequent visits must be separated by at least 2 days but may be up to 1 week apart.
Efficacy will be assessed by measurement of pupil dilation in both eyes.
Safety assessments will include slit lamp examination (SLE) of both eyes and measurement of vital signs (blood pressure [BP]/heart rate [HR]) and adverse events, as well as an ocular discomfort survey
Absorption will be assessed through blood plasma analysis to detect free phenylephrine.
- Conditions
- Mydriasis
- Being tested
- MDD-administered EYN-1601, Phenylephrine 2.5% Eyedrop, Phenylephrine 10% Eyedrop
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDD-administered EYN-1601Combination product
Also called MiDD-administered phenylephrine hydrochloride 10%
Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery
Phenylephrine 2.5% EyedropDrug
Phenylephrine hydrochloride ophthalmic solution 2.5% eyedrop
Phenylephrine 10% EyedropDrug
Phenylephrine hydrochloride ophthalmic solution 10% eyedrop
| Study group | Role | What they receive |
|---|---|---|
| MDD-administered EYN-1601 | Experimental | EYN-1601 Ophthalmic Solution administered using the Eyenovia MDD Receives: Combination Product: MDD-administered EYN-1601 |
| Phenylephrine 2.5% Eyedrop | Active comparator | Phenylephrine Hydrochloride Ophthalmic Solution 2.5% administered as an eyedrop Receives: Drug: Phenylephrine 2.5% Eyedrop |
| Phenylephrine 10% Eyedrop | Active comparator | Phenylephrine Hydrochloride Ophthalmic Solution 10% administered as an eyedrop Receives: Drug: Phenylephrine 10% Eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Dilation
Mean change in pupil diameter from baseline (prior to study drug administration)
Measured: 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug
Secondary outcomes (3)
Blood Pressure
Mean change in blood pressure from baseline (prior to study drug administration)
Measured: 10, 15, 30, 45 and 60 minutes post administration of study drug
Heart Rate
Mean change in heart rate from baseline (prior to study drug administration)
Measured: 10, 15, 30, 45 and 60 minutes post administration of study drug
PK (Concentration of free phenylephrine in the blood plasma)
Concentration of free phenylephrine in the blood plasma
Measured: 20 minutes post administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MydriasisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenovia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946125
- Sponsor's protocol ID
- EYN-1601-101
- Status last verified
- Jul 2022
- First submitted
- 24 Oct 2016
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Observer-Masked, Active-Controlled, Phase 2 Study of the Safety, Efficacy and Pharmacokinetics of EYN-1601 in Dilation of the Pupil
- ClinicalTrials.gov ID
- NCT02946125
- Acronym / sponsor ID
- EYN-1601-101
- Conditions
- Mydriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eyenovia Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.
Detailed description
EYN-1601 delivered topically as a microdose via a proprietary delivery system (the Eyenovia Multi-Dose Device [MDD] system) is being investigated for dilation of the pupil for ophthalmic examinations and procedures. Phenylephrine hydrochloride, a sympathetic α1-adrenergic agonist, has been used for pupil dilation for over 70 years. The mydriatic action of phenylephrine is due to its stimulation of the α1 receptors of the radial muscle of the iris, which causes the muscle fibers to contract and results in pupil dilation.
When conducting a variety of ophthalmological procedures, it is necessary to dilate (enlarge) the pupil to allow an unobstructed view of the lens and retina, as well as the optic nerve. The degree of pupil dilation required is somewhat dependent on the procedure being performed. Eyenovia, the Sponsor, is a specialty pharmaceutical company focused on the development of ophthalmic drug products that can be delivered in small volumes, ie, via microdosing, in order to maximize therapeutic control and minimize systemic absorption. To achieve this goal, Eyenovia is developing a drug/device combination product to allow accurate topical ocular delivery of controlled quantities of specific active pharmaceutical ingredients.
Phenylephrine has been known to cause systemic cardiovascular effects in some patients when dosed via the topical ocular route including hypertension, tachycardia, and more rarely, arrhythmia and stroke, especially in those patients with pre-existing heart conditions. These risks are even more relevant when phenylephrine hydrochloride ophthalmic solution 10% is used in circumstances where a greater degree of mydriasis is required. Microdosing with the Eyenovia MDD system is expected to significantly reduce or eliminate these risks while allowing the same degree of mydriasis produced with the currently approved products.
Subjects (healthy volunteers) will be screened for eligibility and 12 subjects that meet inclusion/exclusion criteria will be enrolled into the study. All subjects will be followed through the same pre-specified treatment visit schedule at which the 3 study drugs are administered (phenylephrine 2.5% eyedrops at Visit 1, phenylephrine 10% eyedrops at Visit 2 and EYN-1601 MDD at Visit 3). At each treatment visit, baseline measurements will be taken prior to study medication administration.
Subjects will participate in safety, efficacy, and pharmacokinetic assessments. Subsequent visits must be separated by at least 2 days but may be up to 1 week apart.
Efficacy will be assessed by measurement of pupil dilation in both eyes.
Safety assessments will include slit lamp examination (SLE) of both eyes and measurement of vital signs (blood pressure [BP]/heart rate [HR]) and adverse events, as well as an ocular discomfort survey
Absorption will be assessed through blood plasma analysis to detect free phenylephrine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDD-administered EYN-1601 | Experimental | Combination Product: MDD-administered EYN-1601EYN-1601 Ophthalmic Solution administered using the Eyenovia MDD |
| Phenylephrine 2.5% Eyedrop | Active comparator | Drug: Phenylephrine 2.5% EyedropPhenylephrine Hydrochloride Ophthalmic Solution 2.5% administered as an eyedrop |
| Phenylephrine 10% Eyedrop | Active comparator | Drug: Phenylephrine 10% EyedropPhenylephrine Hydrochloride Ophthalmic Solution 10% administered as an eyedrop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1.
- Provide signed written consent prior to participation in any study-related procedures
Key exclusion criteria (26 listed)
- Pregnancy or lactation.
- History of diabetes.
- History of cardiac, renal, or hepatic impairment or disease.
- Allergy to phenylephrine hydrochloride.
- Allergy to benzalkonium chloride.
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 |
|---|---|---|
| MDD-administered EYN-1601Also: MiDD-administered phenylephrine hydrochloride 10%Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery | Combination product | MDD-administered EYN-1601 |
| Phenylephrine 2.5% EyedropPhenylephrine hydrochloride ophthalmic solution 2.5% eyedrop | Drug | Phenylephrine 2.5% Eyedrop |
| Phenylephrine 10% EyedropPhenylephrine hydrochloride ophthalmic solution 10% eyedrop | Drug | Phenylephrine 10% Eyedrop |
Primary outcome
Pupil Dilation
Time frame: 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug
Mean change in pupil diameter from baseline (prior to study drug administration)
3 secondary outcomes
Blood Pressure
Time frame: 10, 15, 30, 45 and 60 minutes post administration of study drug
Heart Rate
Time frame: 10, 15, 30, 45 and 60 minutes post administration of study drug
PK (Concentration of free phenylephrine in the blood plasma)
Time frame: 20 minutes post administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Mydriasis
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Recruiting
Cochlear Implanted Listening Effort and Hearing Attention
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Not yet recruitingObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDD-administered EYN-1601, Phenylephrine 2.5% Eyedrop and Phenylephrine 10% Eyedrop in people with Mydriasis, run by Eyenovia Inc. 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 26 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 27 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pupil Dilation (time frame: 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug). 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 27 Jul 2022.