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

NCT03751631 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EYN-MYD-TP-31
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs 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)

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

  35 minutes after initial dose

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

  35 minutes after initial dose

Study Arms (6)

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

OTHER

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

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

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

OTHER

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

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

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

OTHER

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

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

1-TR, 2-PE, 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 study drug in each eye.

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

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

OTHER

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

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

1-PE, 2-TR, 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 study drug in each eye.

Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

Interventions

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) DRUG

Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Also known as: Mydcombi

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

Tropicamide 1% ophthalmic solution (TR) DRUG

Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser

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

Phenylephrine 2.5% ophthalmic solution (PE) DRUG

Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

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

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 (1)

WCCT

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Mydriasis

Interventions

Tropicamide; Phenylephrine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

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 drug administered and all study personnel conducting ophthalmic assessments after drug 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, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 23, 2018
• Study Start: November 15, 2018
• Primary Completion: January 11, 2019
• Study Completion: January 11, 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 (1)