Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT05622435
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Sponsor:
Laboratoires Thea
Organization:
Study Overview
Official Title:
Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: