An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)
| Registry | NCT03480906 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, crossover, masking: single, other |
| Enrollment | 30 (Actual) |
| Sponsor | Eyenovia Inc. (Industry) |
| Conditions | Intraocular Pressure |
| Interventions | Latanoprost (Drug) |
| Dates | start 2018-03-12, primary completion 2018-03-17, completion 2018-03-17, first posted 2018-03-29, last updated 2018-07-26 |
| Locations | 1 site in Panama |
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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)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Microdose administration | Experimental | Drug: Latanoprost | Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD |
| Eyedrop administration | Active comparator | Drug: Latanoprost | Latanoprost ophthalmic solution administered as an eyedrop |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Clinica de Ojos Orillac-Calvo | Panama City | Panama |