Intraocular Pressure
Conditions
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)
Interventions
DRUGLatanoprost
Latanoprost ophthalmic solution administered as a microdose spray
Sponsors
Eyenovia Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful microtherapeutic administration to the ocular surface | Treatment Day 3 | Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer |
Countries
Panama
Outcome results
None listed