An interventional study of T10070, Plastic tube with a roll-on applicator filled with an ointment in Healthy Volunteers, sponsored by Laboratoires Thea. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.
Sponsored by Laboratoires Thea · Not applicable, Interventional, and Other
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:
Laboratoires Thea is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Inclusion Criteria:
Main Exclusion Criteria:
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.
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.
Time frame: 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)").
Time frame: 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").
Time frame: Local tolerance assessed at Day 7/Day 9
Subject questionnaire on product usability
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)
Time frame: Day 7/Day 9
Adverse Events
Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.
Time frame: Day 7/Day 9
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Laboratoires Thea