Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622435
• Other study ID #: LT10070-001
• Status: Completed
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: November 10, 2022

Study information

• Verified date: December 2022
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 10, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Poland	Eurofins Dermscan Poland	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Adverse Events	Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.	Day 7/Day 9