Healthy Volunteers
Conditions
Brief summary
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
Interventions
DEVICET10070, Plastic tube with a roll-on applicator filled with an ointment
6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days.
Sponsors
Laboratoires Thea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in clinical examination on eyes and peri-ocular skin | signs assessment at Day 0 and Day 7/Day 9 | 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. |
| Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects | Signs assessment at Day 0 and Day 7/Day 9 | A subjective tolerance evaluation will be performed before and after product use using 5-point structured scales (from No reaction (0) to Severe (4)). |
| Local tolerance assessed by Investigator | Local tolerance assessed at Day 7/Day 9 | Assessed using a 4-point scale (from Bad tolerance to Very good tolerance). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject questionnaire on product usability | Day 7/Day 9 | 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) |
| Adverse Events | Day 7/Day 9 | Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE. |
Countries
Poland
Outcome results
None listed