Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: T10070, Plastic tube with a roll-on applicator filled with an ointment

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-288
    • Eurofins Dermscan Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T10070	Device: T10070, 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratoires Thea
• Investigators: Principal Investigator: Ewa Paw, Doctor, Eurofins Dermscan Poland

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LT10070-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No