Evaluation of Pupil Dilation Speed With the MAP Dispenser

NCT04907474 | Completed Phase 4 Results

• 1 other identifier: EYN-MYD-TP-41
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Conditions

Mydriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  35 minutes post drug administration

Study Arms (2)

Sequence AB

OTHER

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

Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

Sequence BA

OTHER

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

Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

Interventions

tropicamide-phenylephrine fixed combination ophthalmic solution DRUG

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

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Photopic screening pupil diameter ≤ 3.5 mm in each eye

You may not qualify if:

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

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (1)

CODET Vision Institute

Tijuana, Estado de Baja California, 22010, Mexico

Location

Related Publications (1)

• Chayet A, Ramirez A, Scott B, Whitcomb J, Lam P, Ianchulev T. Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet(R). Ther Deliv. 2023 Feb;14(2):93-103. doi: 10.4155/tde-2022-0061. Epub 2023 May 9.

  PMID: 37158245 DERIVED

MeSH Terms

Conditions

Mydriasis

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Results Point of Contact

• Title: Michael Rowe
• Organization: Eyenovia, Inc.

mmrowe@eyenovia.com

833-393-6684

Study Officials

• Tsontcho Ianchulev, MD, MPH

  Eyenovia Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only 1 mist or 2 mists of the drug will be administered per treatment visit and will occur in a randomized sequence order using on of the two sequences AB or BA where A is 1 mist of the fixed combination and B is 2 mists of the fixed combination
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects received both treatments. Subjects were randomized to treatment order

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: May 24, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)