Status:
COMPLETED
Eyenovia MiDD Usability Study
Lead Sponsor:
Eyenovia Inc.
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03480906
Start Date
March 12 2018
End Date
March 17 2018
Last Update
July 26 2018
Active Locations (1)
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1
Clinica de Ojos Orillac-Calvo
Panama City, Panama