Eyenovia MiDD Usability Study

Intraocular Pressure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480906
• Other study ID #: EYN-POC-PG-21
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intraocular Pressure

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