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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eyenovia Inc.
• Treatments: Ophthalmic Solutions; Oxymetazoline; Pharmaceutical Solutions; Phenylephrine

Criteria

Inclusion Criteria:

• 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

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.