Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: T10070, Plastic tube with a roll-on applicator filled with an ointment

• Registration Number: NCT05622435
• Lead Sponsor: Laboratoires Thea

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-12
• Study Start: 2022-10-17
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-18
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T10070	T10070, Plastic tube with a roll-on applicator filled with an ointment	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse Events	Day 7/Day 9	Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.
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)

Trial Locations

Locations (1)

Eurofins Dermscan Poland; 🇵🇱 Gdańsk, Poland