Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

NCT05622435 | Completed

• 1 other identifier: LT10070-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Subject questionnaire on product usability

  Day 7/Day 9

• Adverse Events

  Day 7/Day 9

Study Arms (1)

T10070

EXPERIMENTAL

Device: T10070, Plastic tube with a roll-on applicator filled with an ointment

Interventions

T10070, Plastic tube with a roll-on applicator filled with an ointment DEVICE

6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days.

T10070

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent signed and dated
• Subject ≥ 18 years old
• Healthy volunteer
• Normal ocular examination in both eyes
• Normal skin examination in both eyes

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

Location

Study Officials

• Ewa Paw, Doctor

  Eurofins Dermscan Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 18, 2022
• Study Start: October 17, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)