Eyenovia MiDD Usability Study

• Status: Completed
• Trial end date: 2018-03-17
• Target enrollment: 0
• Participant gender: All

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)

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eyenovia Inc.
• Treatments: Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions

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