Eyenovia MiDD Usability Study | NCT03480906

Studies
Eyenovia MiDD Usability Study

NCT03480906

Sponsor

Eyenovia Inc.

Status

Completed

Last Update Posted

Jul 26, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Intraocular Pressure

Interventions

Latanoprost
Latanoprost

Countries

Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2018Actual

Primary Completion Date

Mar 17, 2018Actual

Completion Date

Mar 17, 2018Actual

First Submitted Date

Mar 13, 2018

First Submission Date that Met QC Criteria

Mar 26, 2018

First Posted Date

Mar 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Microdose administration	Experimental	Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD	Drug: Latanoprost
Eyedrop administration	Active Comparator	Latanoprost ophthalmic solution administered as an eyedrop	Drug: Latanoprost

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Latanoprost	Drug	Latanoprost ophthalmic solution administered as a microdose spray	Microdose administration

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reuben Orillac, MD	Clinica de Ojos Orillac-Calvo	Principal Investigator
Ernesto Calvo, MD	Clinica de Ojos Orillac-Calvo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica de Ojos Orillac-Calvo		Panama City			Panama

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077338	Latanoprost

Ancestor Terms

ID	Term
D011461	Prostaglandins F, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided