Evaluation of Pupil Dilation Speed With the MAP Dispenser

• Status: Completed
• Trial end date: 2021-06-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eyenovia Inc.
• Treatments: Ophthalmic Solutions; Oxymetazoline; Phenylephrine; Tropicamide

Criteria

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.