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

Eyenovia Inc.70 enrolled

Overview

This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Mydriasis

Interventions

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Tropicamide 1% ophthalmic solution (TR)DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

Phenylephrine 2.5% ophthalmic solution (PE)DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

WCCT

Cypress, California, United States

Outcomes

Primary Outcomes

Change in Pupil Diameter From Baseline

Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome.

Time frame: 35 minutes after initial dose

Data from ClinicalTrials.gov

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