The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.
This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
42
Non-invasive ocular device
Academic Hospital Maastricht
Maastricht, Netherlands
Change from baseline in terms of ocular irritation
Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.
Time frame: 28 days
Total time of Ocular Coil retention
The total number of days that the Ocular Coil is worn by the participant (from placement until removal) is recorded.
Time frame: 28 days
Percentage of Participants in Each Response Category of Subject Comfort
Subject comfort is assessed via a custom-made questionnaire. This questionnaire includes several questions related to eye comfort (itchy feeling, foreign feeling, etc.) and uses a 5-point scale (from agree to do not agree) and a 4-point scale (from always to never). The percentage of participants in each response category is recorded.
Time frame: 28 days
Incidence of ocular adverse events
Incidence of ocular adverse events related to the Ocular Coil or the associated procedures (placement and removal) is evaluated.
Time frame: 28 days
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