Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (MIST-2)

March 16, 2022 updated by: Eyenovia Inc.

A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then either the study drug or placebo was administered to both eyes. Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes. Participants' treatment assignments for each treatment visit were equally randomized using 1 of 2 sequences - ABB or BAA, where A was the study drug and B was the placebo.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
        • Keystone Research
      • San Antonio, Texas, United States, 78229
        • R&R Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
  • Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1-TR/PE, 2-Placebo, 3-Placebo
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)
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Other Names:
  • Mydcombi
Drug: Placebo
Eyewash administered with the Optejet microdose dispenser
OTHER: 1-Placebo, 2-Placebo, 3-TR/PE
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)
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Other Names:
  • Mydcombi
Drug: Placebo
Eyewash administered with the Optejet microdose dispenser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pupil Diameter From Baseline
Time Frame: 35 minutes after initial dose

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication
Time Frame: 35 minutes after initial dose
The percent of eyes with pupil diameter 6.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 69 participants received each medication. Data is reported separately for the right and left eyes of the 69 participants. A higher percentage indicates a better outcome.
35 minutes after initial dose
Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication
Time Frame: 35 minutes after initial dose
The percent of eyes with pupil diameter 7.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 69 participants received each solution. Data is reported separately for the right and left eyes of the 69 participants. A higher percentage indicates a better outcome.
35 minutes after initial dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyenovia Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

January 21, 2019

Study Completion (ACTUAL)

January 21, 2019

Study Registration Dates

First Submitted

November 14, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYN-MYD-TP-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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