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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03480906
Other study ID # EYN-POC-PG-21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2018
Est. completion date March 17, 2018

Study information

Verified date July 2018
Source Eyenovia Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 17, 2018
Est. primary completion date March 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Latanoprost
Latanoprost ophthalmic solution administered as a microdose spray
Latanoprost
Latanoprost ophthalmic solution administered as an eyedrop

Locations

Country Name City State
Panama Clinica de Ojos Orillac-Calvo Panama City

Sponsors (1)

Lead Sponsor Collaborator
Eyenovia Inc.

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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