Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03751098
Recruitment Status : Completed
First Posted : November 23, 2018
Results First Posted : March 18, 2022
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Eyenovia Inc.

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.

Condition or disease Intervention/treatment Phase
Mydriasis Drug: Tropicamide/Phenylephrine ophthalmic solution (TR/PE) Drug: Placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Participant, Outcomes 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.
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 21, 2019


Arm Intervention/treatment
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 Name: Mydcombi

Drug: Placebo
Eyewash administered with the Optejet microdose dispenser

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 Name: Mydcombi

Drug: Placebo
Eyewash administered with the Optejet microdose dispenser




Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751098


Locations
Layout table for location information
United States, Texas
Keystone Research
Austin, Texas, United States, 78731
R&R Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eyenovia Inc.
Investigators
Layout table for investigator information
Study Director: Tsontcho Ianchulev, MD, MPH Eyenovia Inc.
  Study Documents (Full-Text)

Documents provided by Eyenovia Inc.:
Study Protocol  [PDF] November 20, 2018
Statistical Analysis Plan  [PDF] January 18, 2019
Informed Consent Form  [PDF] November 30, 2018

Layout table for additonal information
Responsible Party: Eyenovia Inc.
ClinicalTrials.gov Identifier: NCT03751098    
Other Study ID Numbers: EYN-MYD-TP-32
First Posted: November 23, 2018    Key Record Dates
Results First Posted: March 18, 2022
Last Update Posted: March 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mydriasis
Pupil Disorders
Eye Diseases
Phenylephrine
Oxymetazoline
Ophthalmic Solutions
Tropicamide
Pharmaceutical Solutions
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents