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

NCT03751098 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EYN-MYD-TP-32
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Mydriasis

Outcome Measures

Primary Outcomes (1)

• 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.

  35 minutes after initial dose

Other Outcomes (2)

• Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication

  35 minutes after initial dose

• Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication

  35 minutes after initial dose

Study Arms (2)

1-TR/PE, 2-Placebo, 3-Placebo

OTHER

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.

Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE); Drug: Placebo

1-Placebo, 2-Placebo, 3-TR/PE

OTHER

Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.

Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE); Drug: Placebo

Interventions

Tropicamide/Phenylephrine ophthalmic solution (TR/PE) DRUG

Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Also known as: Mydcombi

1-Placebo, 2-Placebo, 3-TR/PE; 1-TR/PE, 2-Placebo, 3-Placebo

Placebo DRUG

Eyewash administered with the Optejet microdose dispenser

1-Placebo, 2-Placebo, 3-TR/PE; 1-TR/PE, 2-Placebo, 3-Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written consent and return for all study visits
• Photopic pupil diameter \<= 3.5 mm in each eye

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (2)

Keystone Research

Austin, Texas, 78731, United States

Location

R&R Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Mydriasis

Interventions

Tropicamide

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: VP, Development
• Organization: Eyenovia, Inc.

gclasby@eyenoviabio.com

714-269-8838

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: There were no differences in the presentation of study treatment administered and all study personnel conducting ophthalmic assessments after study treatment administration were masked to treatment assignment.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial was a double-masked, placebo-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. placebo. All participants in the trial were to receive each treatment.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 23, 2018
• Study Start: December 1, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: March 18, 2022
• Results First Posted: March 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)