Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Ocular Coil (left eye) | Experimental | Left eye |
|
| Placebo Ocular Coil (right eye) | Experimental | Right eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular Coil | Device | Non-invasive ocular device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Percentage of Participants in Each Response Category of Subject Comfort |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Hospital Maastricht | Maastricht | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 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. | 28 days |