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CompletedNCT03751098MIST-2Updated Mar 18, 2022Results posted

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

A Phase 3 interventional study of Tropicamide/Phenylephrine ophthalmic solution (TR/PE) and Placebo in Mydriasis, sponsored by Eyenovia Inc.. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Eyenovia Inc. · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mydriasis

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • 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) · Drug: Placebo

  • 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) · Drug: Placebo

Interventions

  • DrugTropicamide/Phenylephrine ophthalmic solution (TR/PE)

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

    Also known as: Mydcombi

  • DrugPlacebo

    Eyewash administered with the Optejet microdose dispenser

05

What researchers measure

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.

    Time frame: 35 minutes after initial dose

Other outcomes

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

    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

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

    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

06

Results

Posted Mar 18, 2022

Participant flow

76 patients signed the study informed consent form and were screened for eligibility between November 19, 2018 and December 14, 2018 at clinical research centers located in San Antonio and Austin, Texas.

Participant flow — Overall Study
Milestone1-TR/PE, 2-Placebo, 3-Placebo1-Placebo, 2-Placebo, 3-TR/PE
Started3733
Completed3732
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryChange 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.

Time frame:
35 minutes after initial dose
Reported as:
Mean · millimeters
Change in Pupil Diameter From Baseline
millimetersTR/PE - Right EyeTR/PE - Left EyePlacebo - Right EyePlacebo - Left Eye
Change in 35-minute pupil diameter4.747 ± 0.73014.779 ± 0.80320.134 ± 0.49720.032 ± 0.4983
Baseline pupil diameter2.597 ± 0.47842.524 ± 0.48022.632 ± 0.52022.559 ± 0.4666
35-minutes pupil diameter7.344 ± 0.79817.304 ± 0.82642.766 ± 0.65982.590 ± 0.5892
Other pre-specifiedProportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication

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
Reported as:
Number · percentage of eyes
Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication
percentage of eyesTR/PE - Right EyeTR/PE - Left EyePlacebo - Right EyePlacebo - Left Eye
Proportion of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication92.894.200
Other pre-specifiedProportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication

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
Reported as:
Number · percentage of eyes
Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication
percentage of eyesTR/PE - Right EyeTR/PE - Left EyePlacebo - Right EyePlacebo - Left Eye
Proportion of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication69.668.100

Adverse events

Collected over Adverse event data was collected over each participant's study participation period, which was a maximum of 14 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tropicamide/Phenylephrine0/69 (0%)0/69 (0%)2/69 (2.9%)
Placebo0/70 (0%)0/70 (0%)0/70 (0%)
Most frequent other events
Most frequent other events
EventTropicamide/PhenylephrinePlacebo
PhotophobiaEye disorders1/690/70
Instillation site painGeneral disorders1/690/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Participants
Mean35.4 ± 14.55
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female33
Male37
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino35
Not Hispanic or Latino35
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American7
White62
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Participants
United States70
Iris Color Category
Iris Color Category(Participants)All Participants
Dark50
Light20
07

Study locations

2 sites
  • Keystone Research
    Austin, Texas 78731, United States
  • R&R Research
    San Antonio, Texas 78229, United States
08

References and documents

Study documents

  • Study protocol · Nov 20, 2018
  • Statistical analysis plan · Jan 18, 2019
  • Informed consent form · Nov 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03751098
Lead sponsor
Eyenovia Inc.
Responsible party
Sponsor
First posted
Nov 23, 2018
Start date
Dec 1, 2018
Primary completion
Jan 21, 2019
Completion
Jan 21, 2019
Results posted
Mar 18, 2022
Last update
Mar 18, 2022

Study contacts

Tsontcho Ianchulev, MD, MPH
study director · Eyenovia Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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