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Completed

NCT Number: NCT03751098

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

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.

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Key information

Conditions

Mydriasis Eye Diseases Pupil Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Keystone Research, Austin, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tropicamide/Phenylephrine ophthalmic solution (TR/PE)

Drug

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

Other names: Mydcombi

Placebo

Drug

Eyewash administered with the Optejet microdose dispenser

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study title

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

Acronym: MIST-2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2018
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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