Overview

Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

Status:
Completed
Trial end date:
2019-01-11
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates pupil dilation using fixed combination phenylephrine-tropicamide vs. phenylephrine only and tropicamide only. Participants must attend 3 visits where 1 of the 3 study drugs will be administered to both eyes. Afterwards, pupil dilation and safety assessments will be performed at specific time intervals.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eyenovia Inc.
Treatments:
Ophthalmic Solutions
Oxymetazoline
Pharmaceutical Solutions
Phenylephrine
Tropicamide
Criteria
Inclusion Criteria:

- Ability to provide written consent and return for all study visits

- Photopic pupil diameter <= 3.5 mm in each eye

Exclusion Criteria:

- Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride

- History of benign prostatic hyperplasia

- Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant,
anticonvulsant, or cholinergic drug

- History of closed-angle glaucoma

- Anatomically narrow anterior chamber angles

- Ocular surgery or laser treatment of any kind

- History of chronic or acute uveitis

- History of traumatic iritis or hyphema

- History of traumatic mydriasis or angle recession

- History of heterochromia

- Irregularly-shaped pupil secondary to ocular trauma or congenital defect.

- History of neurogenic pupil disorder

- History of anterior chamber intraocular lens (IOL) or iris-fixated IOL

- History of iris surgery, iris atrophy, or iris-cornea apposition/touch

- Unwilling or unable to discontinue use of contact lenses at treatment visits.

- Current active eye disease for which topical or systemic ophthalmic medication is
necessary, except for dry eye disease managed using artificial tears.

- Presence of a severe/serious ocular condition, or any other unstable medical condition
that, in the Investigator's opinion, may preclude study treatment and/or follow-up

- Pregnancy or lactation