Evaluation of Pupil Dilation Speed With the MAP Dispenser (SPEED)

Eyenovia

Status and phase: Completed; Phase 4

Conditions: Mydriasis

Treatments: Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04907474

EYN-MYD-TP-41

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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61 participants in 2 patient groups

Sequence AB

Other group

Description:

Sequence AB: 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser

Treatment:

Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

Sequence BA

Other group

Description:

Sequence BA: 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser

Treatment:

Drug: tropicamide-phenylephrine fixed combination ophthalmic solution