MedTrace Logo

Study of the Safety, Efficacy and PK of EYN-1601 in Dilation of the Pupil

NCT02946125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-07-27

No results posted yet for this study

Summary

This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions.

Conditions

  • Mydriasis

Interventions

COMBINATION_PRODUCT

MDD-administered EYN-1601

Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery

DRUG

Phenylephrine 2.5% Eyedrop

Phenylephrine hydrochloride ophthalmic solution 2.5% eyedrop

DRUG

Phenylephrine 10% Eyedrop

Phenylephrine hydrochloride ophthalmic solution 10% eyedrop

Sponsors & Collaborators

  • Eyenovia Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946125 on ClinicalTrials.gov