Evaluation of Pupil Dilation Speed With the MAP Dispenser

Eyenovia Inc.61 enrolled

Overview

1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation

After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter. Pupil dilation for each treatment will be compared at each time interval.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Mydriasis

Interventions

tropicamide-phenylephrine fixed combination ophthalmic solutionDRUG

Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Photopic screening pupil diameter ≤ 3.5 mm in each eye Exclusion Criteria: 1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride. 2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period. 3. History of closed-angle glaucoma. 4. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye). 5. Ocular surgery or laser treatment of any kind prior to the Screening Visit. 6. History of iris trauma, surgery, or atrophy. 7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

Locations (1)

CODET Vision Institute

Tijuana, Estado de Baja California, Mexico

Outcomes

Primary Outcomes

Mean Change in Pupil Diameter From Baseline

The primary performance endpoint is Mean Change in pupil diameter at 35 minutes versus per-visit baseline, as measured by digital pupillometry in highly photopic conditions. The highly photopic condition was established using a fully-charged transilluminator (muscle light) at the brightest setting.

Time frame: 35 minutes post drug administration

Data from ClinicalTrials.gov

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