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CompletedNCT03480906Updated Jul 26, 2018

Eyenovia MiDD Usability Study

An interventional study of Latanoprost and Latanoprost in Intraocular Pressure, sponsored by Eyenovia Inc.. Completed at 1 site in Panama. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-26.

Sponsored by Eyenovia Inc. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Intraocular Pressure
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Microdose administration

    Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD

    Drug: Latanoprost

  • Active comparator
    Eyedrop administration

    Latanoprost ophthalmic solution administered as an eyedrop

    Drug: Latanoprost

Interventions

  • DrugLatanoprost

    Latanoprost ophthalmic solution administered as a microdose spray

  • DrugLatanoprost

    Latanoprost ophthalmic solution administered as an eyedrop

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Treatment Day 3

06

Study locations

1 site
  • Clinica de Ojos Orillac-Calvo
    Panama City, Panama
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03480906
Lead sponsor
Eyenovia Inc.
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Mar 12, 2018
Primary completion
Mar 17, 2018
Completion
Mar 17, 2018
Last update
Jul 26, 2018

Study contacts

Reuben Orillac, MD
principal investigator · Clinica de Ojos Orillac-Calvo
Ernesto Calvo, MD
principal investigator · Clinica de Ojos Orillac-Calvo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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