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OpenTrials
Completed

NCT Number: NCT05622435

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Dermscan Poland

Gdansk, 80-288, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in clinical examination on eyes and peri-ocular skin

    Time frame: 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.

  2. Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects

    Time frame: 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)").

  3. Local tolerance assessed by Investigator

    Time frame: Local tolerance assessed at Day 7/Day 9

    Assessed using a 4-point scale (from "Bad tolerance" to "Very good tolerance").

Secondary outcomes

  1. Subject questionnaire on product usability

    Time frame: 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)

  2. Adverse Events

    Time frame: Day 7/Day 9

    Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2022
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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