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

• Status: Completed
• Trial end date: 2019-01-21
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates pupil dilation using fixed combination phenylephrine-tropicamide vs. a placebo. Participants must attend 3 visits where either the investigational drug or a placebo 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