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Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

NCT05622435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-12-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Ewa Paw, Doctor · Eurofins Dermscan Poland

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-17
Primary Completion
2022-11-10
Completion
2022-11-10

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622435 on ClinicalTrials.gov