Eyenovia MiDD Usability Study

NCT ID: NCT03480906

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2018-03-17

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)

Conditions

Intraocular Pressure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Microdose administration

Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD

Group Type: EXPERIMENTAL

Latanoprost

Intervention Type: DRUG

Latanoprost ophthalmic solution administered as a microdose spray

Eyedrop administration

Latanoprost ophthalmic solution administered as an eyedrop

Group Type: ACTIVE_COMPARATOR

Latanoprost

Intervention Type: DRUG

Latanoprost ophthalmic solution administered as an eyedrop

Interventions

Latanoprost

Latanoprost ophthalmic solution administered as a microdose spray

Intervention Type: DRUG

Latanoprost

Latanoprost ophthalmic solution administered as an eyedrop

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eyenovia Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reuben Orillac, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica de Ojos Orillac-Calvo

Ernesto Calvo, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica de Ojos Orillac-Calvo

Locations

Clinica de Ojos Orillac-Calvo

Panama City, , Panama

Countries

Panama

Other Identifiers

EYN-POC-PG-21

Identifier Type: -

Identifier Source: org_study_id