Eyenovia MiDD Usability Study

July 24, 2018 updated by: Eyenovia Inc.

An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • Clinica de ojos Orillac-Calvo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microdose administration
Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD
Drug: Latanoprost
Latanoprost ophthalmic solution administered as a microdose spray
Drug: Latanoprost
Latanoprost ophthalmic solution administered as an eyedrop
Active Comparator: Eyedrop administration
Latanoprost ophthalmic solution administered as an eyedrop
Drug: Latanoprost
Latanoprost ophthalmic solution administered as a microdose spray
Drug: Latanoprost
Latanoprost ophthalmic solution administered as an eyedrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful microtherapeutic administration to the ocular surface
Time Frame: 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
Treatment Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyenovia Inc.

Investigators

  • Principal Investigator: Reuben Orillac, MD, Clinica de ojos Orillac-Calvo
  • Principal Investigator: Ernesto Calvo, MD, Clinica de ojos Orillac-Calvo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Actual)

March 17, 2018

Study Completion (Actual)

March 17, 2018

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYN-POC-PG-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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