A Phase 2 interventional study of MDD-administered EYN-1601 and Phenylephrine 2.5% Eyedrop in Mydriasis, sponsored by Eyenovia Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Eyenovia Inc. · Phase 2, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's enrollment of 12 is below the median of 61 across 35 interventional studies indexed under Mydriasis.
Browse Mydriasis studies →Eyenovia Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EYN-1601 Ophthalmic Solution administered using the Eyenovia MDD
Combination Product: MDD-administered EYN-1601
Phenylephrine Hydrochloride Ophthalmic Solution 2.5% administered as an eyedrop
Drug: Phenylephrine 2.5% Eyedrop
Phenylephrine Hydrochloride Ophthalmic Solution 10% administered as an eyedrop
Drug: Phenylephrine 10% Eyedrop
Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery
Also known as: MiDD-administered phenylephrine hydrochloride 10%
Phenylephrine hydrochloride ophthalmic solution 2.5% eyedrop
Phenylephrine hydrochloride ophthalmic solution 10% eyedrop
Pupil Dilation
Mean change in pupil diameter from baseline (prior to study drug administration)
Time frame: 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug
Blood Pressure
Mean change in blood pressure from baseline (prior to study drug administration)
Time frame: 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)
Time frame: 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
Time frame: 20 minutes post administration of study drug
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Eyenovia Inc.