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

Completed · Phase 3 · Has a placebo group

Conditions studied: Mydriasis

In brief

This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

Key facts

Study ID

NCT03751098

Run by

Eyenovia Inc.

People needed

76

Starts

2018-12-01

Expected to finish

2019-01-21

Last updated by the study team

2022-03-18

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to provide written consent and return for all study visits
• Photopic pupil diameter <= 3.5 mm in each eye

You may not qualify if…

• 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

Where it is running

• Keystone Research — Austin, Texas, United States
• R&R Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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