Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2022-11-10

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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T10070

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes