Evaluation of Pupil Dilation Speed With the MAP Dispenser

Mydriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907474
• Other study ID #: EYN-MYD-TP-41
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2021
• Est. completion date: June 3, 2021

Study information

• Verified date: August 2021
• Source: Eyenovia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Photopic screening pupil diameter = 3.5 mm in each eye

Exclusion Criteria:

1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.

2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.

3. History of closed-angle glaucoma.

4. Anatomically narrow anterior chamber angles (Van Herrick grade = 2 in either eye).

5. Ocular surgery or laser treatment of any kind prior to the Screening Visit.

6. History of iris trauma, surgery, or atrophy.

7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

Related Conditions & MeSH terms

• Mydriasis

Intervention

Drug:
• tropicamide-phenylephrine fixed combination ophthalmic solution
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

Locations

Country	Name	City	State
Mexico	CODET Vision Institute	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in pupil diameter from baseline		35 minutes post drug administration