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

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ClinicalTrials.gov Identifier: NCT03751631
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eyenovia Inc.

Brief Summary:
This study evaluates pupil dilation using fixed combination phenylephrine-tropicamide vs. phenylephrine only and tropicamide only. Participants must attend 3 visits where 1 of the 3 study drugs will be administered to both eyes. Afterwards, pupil dilation and safety assessments will be performed at specific time intervals.

Condition or disease Intervention/treatment Phase
Mydriasis Drug: Phenylephrine 2.5%-tropicamide 1% ophthalmic solution Drug: Phenylephrine 2.5% ophthalmic solution Drug: Tropicamide 1% ophthalmic solution Phase 3

Detailed Description:
Volunteer participants will be screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria will be scheduled for 3 treatment visits, which must occur at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements will be taken, then 1 of the 3 study drugs will be administered to both eyes. Afterwards, efficacy and safety assessments will be performed at specific time intervals. Study drug administration for each subject will be equally randomized to 1 of 6 possible sequences of study drugs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This trial is a double-masked, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination study drug vs. the 2 individual components in the fixed combination drug.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: There will be no differences in the presentation of study drug administered and all study personnel conducting ophthalmic assessments after study drug administration will be masked to treatment assignment.
Primary Purpose: Diagnostic
Official Title: A Double-Masked, Active-Controlled Study of the Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil
Actual Study Start Date : November 15, 2018
Actual Primary Completion Date : January 11, 2019
Actual Study Completion Date : January 11, 2019


Arm Intervention/treatment
Experimental: Phenylephrine-tropicamide
Fixed combination phenylephrine 2.5%-tropicamide 1% ophthalmic solution administered using a microdose dispenser
Drug: Phenylephrine 2.5%-tropicamide 1% ophthalmic solution
Fixed combination phenylephrine 2.5%-tropicamide 1% ophthalmic solution administered with a microdose dispenser

Active Comparator: Phenylephrine
Phenylephrine 2.5% ophthalmic solution administered using a microdose dispenser
Drug: Phenylephrine 2.5% ophthalmic solution
Phenylephrine 2.5% ophthalmic solution administered with a microdose dispenser

Active Comparator: Tropicamide
Tropicamide 1% ophthalmic solution administered using a microdose dispenser
Drug: Tropicamide 1% ophthalmic solution
Tropicamide 1% ophthalmic solution administered with a microdose dispenser




Primary Outcome Measures :
  1. Change in pupil diameter [ Time Frame: Baseline and 35 minutes after initial dose ]
    Difference in pupil diameter vs. baseline measured in highly photopic conditions


Other Outcome Measures:
  1. Eyelid erythema [ Time Frame: Baseline and 180 minutes after initial dose ]
    Eyelid erythema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal to 3 (severe)

  2. Eyelid edema [ Time Frame: Baseline and 180 minutes after initial dose ]
    Eyelid edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal to 3 (severe)

  3. Conjunctival hyperemia [ Time Frame: Baseline and 180 minutes after initial dose ]
    Conjunctival hyperemia evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)

  4. Conjunctival edema [ Time Frame: Baseline and 180 minutes after initial dose ]
    Conjunctival edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)

  5. Sclera appearance [ Time Frame: Baseline and 180 minutes after initial dose ]
    Scleral appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"

  6. Corneal edema [ Time Frame: Baseline and 180 minutes after initial dose ]
    Corneal edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)

  7. Corneal staining [ Time Frame: Baseline and 180 minutes after initial dose ]
    Corneal staining evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)

  8. Anterior chamber cells [ Time Frame: Baseline and 180 minutes after initial dose ]
    Anterior chamber cells evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 4 (hypopyon)

  9. Anterior chamber flare [ Time Frame: Baseline and 180 minutes after initial dose ]
    Anterior chamber flare evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 3 (milky aqueous)

  10. Iris appearance [ Time Frame: Baseline and 180 minutes after initial dose ]
    Iris appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"

  11. Lens opacity [ Time Frame: Baseline and 180 minutes after initial dose ]
    Lens opacity evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 3 (dense)

  12. Anterior vitreous appearance [ Time Frame: Baseline and 180 minutes after initial dose ]
    Anterior vitreous appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"

  13. Adverse events [ Time Frame: Basline, 5 minutes and 180 minutes after initial dose ]
    Untoward medical occurrences

  14. Intraocular pressure [ Time Frame: Baseline and 65 minutes after initial dose ]
    Intraocular pressure measured by tonometry

  15. Visual acuity [ Time Frame: Baseline and 180 minutes after initial dose ]
    Visual acuity measured using ETDRS lighted chart



Information from the National Library of Medicine

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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): NCT03751631


Locations
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United States, California
WCCT
Cypress, California, United States, 90630
Sponsors and Collaborators
Eyenovia Inc.
Investigators
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Study Director: Tsontcho Ianchulev, MD, MPH Eyenovia Inc.

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Responsible Party: Eyenovia Inc.
ClinicalTrials.gov Identifier: NCT03751631     History of Changes
Other Study ID Numbers: EYN-MYD-TP-31
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tropicamide
Mydriasis
Pupil Disorders
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Phenylephrine
Oxymetazoline
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