NCT03751631

Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Eyenovia Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Mydriasis

Interventions

Type	Name	Description
DRUG	Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)	Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
DRUG	Tropicamide 1% ophthalmic solution (TR)	Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser
DRUG	Phenylephrine 2.5% ophthalmic solution (PE)	Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2018-11-23
• Last updated: 2022-03-18
• Results posted: 2022-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study