Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Study Overview
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Brief Summary
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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: ophtalmological examination diary completion to record T10070 applications, potential discomfort/reactions observed and medication taken. complete subject questionnaire about usability of the product

Official Title
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Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: T10070, Plastic tube with a roll-on applicator filled with an ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated Subject ≥ 18 years old Healthy volunteer Normal ocular examination in both eyes Normal skin examination in both eyes Main Exclusion Criteria: Far best-corrected visual acuity (BCVA) ≥ +0.1 LogMar (e.g., ≤ 0.8 in decimal value or ≤ 80/100 Snellen equivalent) Known or suspected hypersensitivity to one of the components of the T10070 History of trauma, infection, clinically significant inflammation within the 3 previous months Ongoing or know history of ocular allergy and/or uveitis and/or viral infection Diagnosed keratoconus Any palpebral abnormality

Ages Eligible for Study
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Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T10070<br> | Device: T10070, Plastic tube with a roll-on applicator filled with an ointment<br>* 6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE. | Day 7/Day 9 |