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Eyenovia MiDD Usability Study

Sponsor
Eyenovia Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03480906
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
5
Actual Duration (Days)
182.6
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
Actual Study Start Date :
Mar 12, 2018
Actual Primary Completion Date :
Mar 17, 2018
Actual Study Completion Date :
Mar 17, 2018

Arms and Interventions

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
Active Comparator: Eyedrop administration

Latanoprost ophthalmic solution administered as an eyedrop

Drug: Latanoprost
Latanoprost ophthalmic solution administered as an eyedrop

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica de Ojos Orillac-Calvo Panama City Panama

Sponsors and Collaborators

  • Eyenovia Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eyenovia Inc.
ClinicalTrials.gov Identifier:
NCT03480906
Other Study ID Numbers:
  • EYN-POC-PG-21
First Posted:
Mar 29, 2018
Last Update Posted:
Jul 26, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Latanoprost

Study Results

No Results Posted as of Jul 26, 2018