Status:
COMPLETED
Evaluation of Pupil Dilation Speed With the MAP Dispenser
Lead Sponsor:
Eyenovia Inc.
Conditions:
Mydriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
Detailed Description
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 randomizatio...
Eligibility Criteria
Inclusion
- 1\. Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion
- 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.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04907474
Start Date
May 24 2021
End Date
June 3 2021
Last Update
January 9 2025
Active Locations (1)
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1
CODET Vision Institute
Tijuana, Estado de Baja California, Mexico, 22010