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The goal of this clinical trial investigation is to evaluate the tolerance of the T10070 on healthy volunteers by clinical examination under ophthalmological control.
Participants will attend 2 visits (inclusion at day 0 and follow-up/final at D7/D9. After inclusion, subjects will have to apply T10070 6 times a day during 7 to 9 days. The following tasks will be asked to participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T10070 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T10070, Plastic tube with a roll-on applicator filled with an ointment | Device | 6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in clinical examination on eyes and peri-ocular skin | A clinical examination will be performed before and after product use on eyes and peri-ocular skin using 5-point structured scales (from "Absence (0)" to "Severe (4)") to evaluate the intensity of several signs. | signs assessment at Day 0 and Day 7/Day 9 |
| Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects | A subjective tolerance evaluation will be performed before and after product use using 5-point structured scales (from "No reaction (0)" to "Severe (4)"). | Signs assessment at Day 0 and Day 7/Day 9 |
| Local tolerance assessed by Investigator | Assessed using a 4-point scale (from "Bad tolerance" to "Very good tolerance"). | Local tolerance assessed at Day 7/Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject questionnaire on product usability | The subjective evaluation of the tested medical device will be assessed by subject by answering a satisfaction questionnaire. For each question, there are 4 possible answers (agree, somewhat agree, somewhat disagree, disagree) | Day 7/Day 9 |
| Adverse Events |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewa Paw, Doctor | Eurofins Dermscan Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Gdansk | 80-288 | Poland |
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Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE. |
| Day 7/Day 9 |