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Study of the Safety, Efficacy and PK of EYN-1601 in Dilation of the Pupil

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Eyenovia Inc.
Information provided by (Responsible Party):
Eyenovia Inc. Identifier:
First received: October 24, 2016
Last updated: October 25, 2016
Last verified: October 2016
This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single micro dose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.

Condition Intervention Phase
Drug: EYN-1601 Ophthalmic Solution
Drug: Phenylephrine Hydrochloride Ophthalmic Solution 2.5%
Drug: Phenylephrine Hydrochloride Ophthalmic Solution 10%
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Eyenovia Inc.:

Primary Outcome Measures:
  • Pupil dilation [ Time Frame: Change from Baseline at 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug ] [ Designated as safety issue: No ]
    Pupil diameter measured at 15, 30, 45, 60, 75, 120, and 180 minutes post administration of each study drug as tested via a hierarchical analysis

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Change from Baseline at 10, 15, 30, 45 and 60 minutes post administration of study drug ] [ Designated as safety issue: Yes ]
    Increase in blood pressure

  • Heart rate [ Time Frame: Change from Baseline at 10, 15, 30, 45 and 60 minutes post administration of study drug ] [ Designated as safety issue: Yes ]
    Increase in heart rate

  • PK (Concentration of free phenylephrine in the blood plasma) [ Time Frame: 20 minutes post administration of study drug ] [ Designated as safety issue: No ]
    Concentration of free phenylephrine in the blood plasma at 20 minutes post administration of study drug

Estimated Enrollment: 12
Study Start Date: October 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EYN-1601
EYN-1601 Ophthalmic Solution
Drug: EYN-1601 Ophthalmic Solution
Active Comparator: Phenylephrine 2.5%
Phenylephrine Hydrochloride Ophthalmic Solution 2.5%
Drug: Phenylephrine Hydrochloride Ophthalmic Solution 2.5%
Active Comparator: Phenylephrine 10%
Phenylephrine Hydrochloride Ophthalmic Solution 10%
Drug: Phenylephrine Hydrochloride Ophthalmic Solution 10%

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 including, it is necessary to dilate (enlarge) the pupil to allow the ophthalmologist to have 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 current approved products.

Subjects (healthy volunteers) will be screened for eligibility and 12 subjects that meet inclusion/exclusion criteria will be enrolled into the study. At each of 3 treatment visits, baseline measurements will be taken and two doses (separated by 5 minutes) in both eyes (OU) of 1 of 3 study drugs will be administered (only 1 drug administered at each treatment visit.

  • EYN-1601 ophthalmic solution
  • Phenylephrine hydrochloride ophthalmic solution 2.5%
  • Phenylephrine hydrochloride ophthalmic solution 2.5%

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 by pupilometer 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or female volunteer at least 18 years of age.
  • Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
  • Provide signed written consent prior to participation in any study-related procedures

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02946125

Contact: Drey Coleman 813-418-7059

United States, California
Artesia, California, United States
Sponsors and Collaborators
Eyenovia Inc.
  More Information

Responsible Party: Eyenovia Inc. Identifier: NCT02946125     History of Changes
Other Study ID Numbers: EYN-1601-101 
Study First Received: October 24, 2016
Last Updated: October 25, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Pupil Disorders
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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 processed this record on October 26, 2016