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)
Verified date | July 2018 |
Source | Eyenovia Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Panama | Clinica de Ojos Orillac-Calvo | Panama City |
Lead Sponsor | Collaborator |
---|---|
Eyenovia Inc. |
Panama,
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 |
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