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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in clinical examination on eyes and peri-ocular skin', 'timeFrame': 'signs assessment at Day 0 and Day 7/Day 9', 'description': '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.'}, {'measure': 'Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects', 'timeFrame': 'Signs assessment at Day 0 and Day 7/Day 9', 'description': 'A subjective tolerance evaluation will be performed before and after product use using 5-point structured scales (from "No reaction (0)" to "Severe (4)").'}, {'measure': 'Local tolerance assessed by Investigator', 'timeFrame': 'Local tolerance assessed at Day 7/Day 9', 'description': 'Assessed using a 4-point scale (from "Bad tolerance" to "Very good tolerance").'}], 'secondaryOutcomes': [{'measure': 'Subject questionnaire on product usability', 'timeFrame': 'Day 7/Day 9', 'description': '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)'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 7/Day 9', 'description': 'Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial investigation is to evaluate the tolerance of the T10070 on healthy volunteers by clinical examination under ophthalmological control.\n\nParticipants 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:\n\n* ophtalmological examination\n* diary completion to record T10070 applications, potential discomfort/reactions observed and medication taken.\n* complete subject questionnaire about usability of the product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent signed and dated\n* Subject ≥ 18 years old\n* Healthy volunteer\n* Normal ocular examination in both eyes\n* Normal skin examination in both eyes\n\nMain Exclusion Criteria:\n\n* Far best-corrected visual acuity (BCVA) ≥ +0.1 LogMar (e.g., ≤ 0.8 in decimal value or ≤ 80/100 Snellen equivalent)\n* Known or suspected hypersensitivity to one of the components of the T10070\n* History of trauma, infection, clinically significant inflammation within the 3 previous months\n* Ongoing or know history of ocular allergy and/or uveitis and/or viral infection\n* Diagnosed keratoconus\n* Any palpebral abnormality'}, 'identificationModule': {'nctId': 'NCT05622435', 'briefTitle': 'Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LT10070-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T10070', 'interventionNames': ['Device: T10070, Plastic tube with a roll-on applicator filled with an ointment']}], 'interventions': [{'name': 'T10070, Plastic tube with a roll-on applicator filled with an ointment', 'type': 'DEVICE', 'description': '6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days.', 'armGroupLabels': ['T10070']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-288', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Eurofins Dermscan Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Ewa Paw, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurofins Dermscan Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}