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

Primary Purpose

Mydriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Placebo
Sponsored by
Eyenovia Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mydriasis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Keystone Research
  • R&R Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
March 16, 2022
Sponsor
Eyenovia Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03751098
Brief Title
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Acronym
MIST-2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eyenovia Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mydriasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-TR/PE, 2-Placebo, 3-Placebo
Arm Type
Other
Arm Description
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.
Arm Title
1-Placebo, 2-Placebo, 3-TR/PE
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
Other Intervention Name(s)
Mydcombi
Intervention Description
Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Eyewash administered with the Optejet microdose dispenser
Primary Outcome Measure Information:
Title
Change in Pupil Diameter From Baseline
Description
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.
Time Frame
35 minutes after initial dose
Other Pre-specified Outcome Measures:
Title
Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication
Description
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.
Time Frame
35 minutes after initial dose
Title
Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication
Description
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.
Time Frame
35 minutes after initial dose

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsontcho Ianchulev, MD, MPH
Organizational Affiliation
Eyenovia Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
R&R Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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