Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Status
Completed
Conditions
Healthy Volunteers
Treatments
Device: T10070, Plastic tube with a roll-on applicator filled with an ointment
Details and patient eligibility
About
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
Enrollment
39 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Other
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
39 participants in 1 patient group
T10070
Experimental group
Treatment:
Device: T10070, Plastic tube with a roll-on applicator filled with an ointment
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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