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Completed
NCT05622435
Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 39
Sponsor: Laboratoires Thea
Location: Poland
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 examinationdiary completion to record T10070 applications, potential discomfort/reactions observed and medication taken.complete subject questionnaire about usability of the product
Eligibility Criteria
Inclusion Criteria:Informed consent signed and datedSubject ≥ 18 years oldHealthy volunteerNormal ocular examination in both eyesNormal skin examination in both eyesMain 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 T10070History of trauma, infection, clinically significant inflammation within the 3 previous monthsOngoing or know history of ocular allergy and/or uveitis and/or viral infectionDiagnosed keratoconusAny palpebral abnormality
Source: ClinicalTrials.gov (NCT05622435). StuddyBuddy aggregates publicly available trial information.