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Completed

NCT Number: NCT03480906

Eyenovia MiDD Usability Study

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)

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica de Ojos Orillac-Calvo

Panama City, Panama

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

latanoprost

Drug

Latanoprost ophthalmic solution administered as a microdose spray

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eyenovia Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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