Back to resultsSafety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (MIST-1)
Primary Purpose
Mydriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)
Tropicamide 1% ophthalmic solution (TR)
Phenylephrine 2.5% ophthalmic solution (PE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Mydriasis
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
Sites / Locations
- WCCT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Other
Other
Other
Other
Other
Other
Arm Label
1-TR/PE, 2-TR, 3-PE
1-TR/PE, 2-PE, 3-TR
1-TR, 2-TR/PE, 3-PE
1-TR, 2-PE, 3-TR/PE
1-PE, 2-TR/PE, 3-TR
1-PE, 2-TR, 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 study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug 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
1. Study Identification
Unique Protocol Identification Number
NCT03751631
Brief Title
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Acronym
MIST-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 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/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs 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 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.
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, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.
Masking
ParticipantOutcomes Assessor
Masking Description
There were no differences in the presentation of drug administered and all study personnel conducting ophthalmic assessments after drug administration were masked to treatment assignment.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-TR/PE, 2-TR, 3-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 study drug in each eye.
Arm Title
1-TR/PE, 2-PE, 3-TR
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 study drug in each eye.
Arm Title
1-TR, 2-TR/PE, 3-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 study drug in each eye.
Arm Title
1-TR, 2-PE, 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 study drug in each eye.
Arm Title
1-PE, 2-TR/PE, 3-TR
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 study drug in each eye.
Arm Title
1-PE, 2-TR, 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 study drug in each eye.
Intervention Type
Drug
Intervention Name(s)
Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)
Other Intervention Name(s)
Mydcombi
Intervention Description
Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Intervention Type
Drug
Intervention Name(s)
Tropicamide 1% ophthalmic solution (TR)
Intervention Description
Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser
Intervention Type
Drug
Intervention Name(s)
Phenylephrine 2.5% ophthalmic solution (PE)
Intervention Description
Phenylephrine 2.5% ophthalmic solution 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
Percentage 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 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome.
Time Frame
35 minutes after initial dose
Title
Percentage 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 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 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
WCCT
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
We'll reach out to this number within 24 hrs