Evaluation of Pupil Dilation Speed With the MAP Dispenser

Phase 4

Completed

• Conditions: Mydriasis
• Interventions: Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

• Registration Number: NCT04907474
• Lead Sponsor: Eyenovia Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-05-24
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Primary Completion: 2021-06-03
• Study Completion: 2021-06-03
• Results First Submitted: 2022-06-07
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence AB	tropicamide-phenylephrine fixed combination ophthalmic solution	Sequence AB: 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Sequence BA	tropicamide-phenylephrine fixed combination ophthalmic solution	Sequence BA: 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser

Primary Outcome Measures

Name	Time	Method
Mean Change in Pupil Diameter From Baseline	35 minutes post drug administration	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.

Trial Locations

Locations (1)

CODET Vision Institute; 🇲🇽 Tijuana, Baja California, Mexico