Healthy VolunteersNCT05622435
Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
A study testing T10070, Plastic tube with a roll-on applicator filled with an ointment in people with Healthy Volunteers, run by Laboratoires Thea at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- T10070, Plastic tube with a roll-on applicator filled with an ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 17 Oct 2022to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated
- Subject ≥ 18 years old
- Healthy volunteer
- Normal ocular examination in both eyes
- Normal skin examination in both eyes
- Main Exclusion Criteria:
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- T10070, Plastic tube with a roll-on applicator filled with an ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T10070, Plastic tube with a roll-on applicator filled with an ointmentDevice
6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days.
| Study group | Role | What they receive |
|---|---|---|
| T10070 | Experimental | Not described Receives: Device: T10070, Plastic tube with a roll-on applicator filled with an ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)").
Measured: 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").
Measured: Local tolerance assessed at Day 7/Day 9
Secondary outcomes (2)
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)
Measured: Day 7/Day 9
Adverse Events
Proportion of subjects experiencing at least one AE/SAE, TEAE related to the device, Serious TEAE.
Measured: Day 7/Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start17 Oct 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ewa Paw, Doctor, Principal investigator, Eurofins Dermscan Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622435
- Sponsor's protocol ID
- LT10070-001
- Status last verified
- Dec 2022
- First submitted
- 12 Oct 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05622435
- Acronym / sponsor ID
- LT10070-001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T10070 | Experimental | Device: T10070, Plastic tube with a roll-on applicator filled with an ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Informed consent signed and dated
- Subject ≥ 18 years old
- Healthy volunteer
- Normal ocular examination in both eyes
- Normal skin examination in both eyes
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T10070, Plastic tube with a roll-on applicator filled with an ointment6 times per day on both (upper and lower) eyelids of right eye during 7 to 9 days. | Device | T10070 |
Primary outcome
Change from baseline in clinical examination on eyes and peri-ocular skin
Time frame: signs assessment at Day 0 and Day 7/Day 9
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.
Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects
Time frame: Signs assessment at Day 0 and Day 7/Day 9
A subjective tolerance evaluation will be performed before and after product use using 5-point structured scales (from "No reaction (0)" to "Severe (4)").
Local tolerance assessed by Investigator
Time frame: Local tolerance assessed at Day 7/Day 9
Assessed using a 4-point scale (from "Bad tolerance" to "Very good tolerance").
2 secondary outcomes
Subject questionnaire on product usability
Time frame: Day 7/Day 9
Adverse Events
Time frame: Day 7/Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewa Paw, Doctor principal investigator
Eurofins Dermscan Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T10070, Plastic tube with a roll-on applicator filled with an ointment in people with Healthy Volunteers, run by Laboratoires Thea at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in clinical examination on eyes and peri-ocular skin (time frame: signs assessment at Day 0 and Day 7/Day 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.