Ocular Coil Drug Delivery Comfort Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.

Official Title
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Evaluation of the Safety and Tolerability of an Ocular Coil

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Ocular Coil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years old Informed and having given informed consent Willing and able to comply with scheduled visits and other study procedures Exclusion Criteria: Subjects with a history of eye disease that can make them vulnerable for irritation by the coil. Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study). Subjects using eye drops (during the study). Subjects with an Oriental/Asian lid crease, because of their narrow fornix. Subjects who do not speak and/or write Dutch properly. Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo Ocular Coil (left eye)<br>Left eye | Device: Ocular Coil<br>* Non-invasive ocular device<br>|
| Experimental: Placebo Ocular Coil (right eye)<br>Right eye | Device: Ocular Coil<br>* Non-invasive ocular device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |