Eyenovia MiDD Usability Study

NCT03480906 | Completed

• 1 other identifier: EYN-POC-PG-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  Treatment Day 3

Study Arms (2)

Microdose administration

EXPERIMENTAL

Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD

Drug: Latanoprost

Eyedrop administration

ACTIVE COMPARATOR

Latanoprost ophthalmic solution administered as an eyedrop

Drug: Latanoprost

Interventions

Latanoprost DRUG

Latanoprost ophthalmic solution administered as a microdose spray

Microdose administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyenovia Inc.: lead

Study Sites (1)

Clinica de Ojos Orillac-Calvo

Panama City, Panama

Location

MeSH Terms

Interventions

Latanoprost

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Reuben Orillac, MD

  Clinica de Ojos Orillac-Calvo

  PRINCIPAL INVESTIGATOR

• Ernesto Calvo, MD

  Clinica de Ojos Orillac-Calvo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 29, 2018
• Study Start: March 12, 2018
• Primary Completion: March 17, 2018
• Study Completion: March 17, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)