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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Eyenovia Inc.

Current Primary Outcome: Pupil dilation [ Time Frame: Change from Baseline at 15, 30, 45, 60, 75, 120 and 180 minutes post administration of study drug ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood Pressure [ Time Frame: Change from Baseline at 10, 15, 30, 45 and 60 minutes post administration of study drug ]
    Increase in blood pressure
  • Heart rate [ Time Frame: Change from Baseline at 10, 15, 30, 45 and 60 minutes post administration of study drug ]
    Increase in heart rate
  • PK (Concentration of free phenylephrine in the blood plasma) [ Time Frame: 20 minutes post administration of study drug ]
    Concentration of free phenylephrine in the blood plasma at 20 minutes post administration of study drug


Original Secondary Outcome: Same as current

Information By: Eyenovia Inc.

Dates:
Date Received: October 24, 2016
Date Started: October 2016
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016