Eyenovia MiDD Usability Study

Not Applicable

Completed

• Conditions: Intraocular Pressure
• Interventions: Drug: Latanoprost

• Registration Number: NCT03480906
• Lead Sponsor: Eyenovia Inc.

Brief Summary

This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-13
• Primary Completion: 2018-03-17
• Study Completion: 2018-03-17
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg
• Willing to forego use of contact lenses during study period
• Presence of cognition an dexterity necessary to follow MiDD drug administration instructions
• Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test

Exclusion Criteria

• Prior clinically significant ocular history or abnormal eye exam
• Use of ocular medication within 30 days of screening
• Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period
• History of drug or alcohol abuse within 1 year of screening
• Lid squeezer
• Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD
• Participation in any interventional study of an investigational drug or device within 30 days of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microdose administration	Latanoprost	Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD
Eyedrop administration	Latanoprost	Latanoprost ophthalmic solution administered as an eyedrop

Primary Outcome Measures

Name	Time	Method
Successful microtherapeutic administration to the ocular surface	Treatment Day 3	Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer

Trial Locations

Locations (1)

Clinica de Ojos Orillac-Calvo; 🇵🇦 Panama City, Panama