Back to resultsEvaluation of Pupil Dilation Speed With the MAP Dispenser (SPEED)
Primary Purpose
Mydriasis
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
tropicamide-phenylephrine fixed combination ophthalmic solution
Sponsored by
About this trial
This is an interventional diagnostic trial for Mydriasis
Eligibility Criteria
Inclusion Criteria:
1. Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion Criteria:
- Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
- Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
- History of closed-angle glaucoma.
- Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
- Ocular surgery or laser treatment of any kind prior to the Screening Visit.
- History of iris trauma, surgery, or atrophy.
- Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
Sites / Locations
- CODET Vision Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1 Mist
2 Mists
Arm Description
One mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Two mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Outcomes
Primary Outcome Measures
Mean change in pupil diameter from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04907474
Brief Title
Evaluation of Pupil Dilation Speed With the MAP Dispenser
Acronym
SPEED
Official Title
A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
June 3, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.
Pupil dilation for each treatment will be compared at each time interval.
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 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Mist
Arm Type
Other
Arm Description
One mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Arm Title
2 Mists
Arm Type
Other
Arm Description
Two mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser
Intervention Type
Drug
Intervention Name(s)
tropicamide-phenylephrine fixed combination ophthalmic solution
Intervention Description
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis
Primary Outcome Measure Information:
Title
Mean change in pupil diameter from baseline
Time Frame
35 minutes post drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion Criteria:
Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
History of closed-angle glaucoma.
Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
Ocular surgery or laser treatment of any kind prior to the Screening Visit.
History of iris trauma, surgery, or atrophy.
Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
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
CODET Vision Institute
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22010
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Pupil Dilation Speed With the MAP Dispenser
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