Eyelid DiseasesPhase 1NCT01086943
Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
A Phase 1 study testing LT2420 in people with Eyelid Diseases, run by Laboratoires Thea at 1 site in United Kingdom.
Trial summary
The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids. Prospective, non comparative, open, monocentre study. The objectives are: To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application To evaluate… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eyelid Diseases
- What is being tested?
- LT2420
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged from 18 to 80 years old.
- Healthy volunteers.
- For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
- Normal ocular examination in both eyes.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids.
Prospective, non comparative, open, monocentre study.
The objectives are:
- To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
- To evaluate the ocular surface, NIBUT and IOP before and after device application
- To determine the acceptability of healthy volunteers on the practical use of this device
The subjects will attend 2 visits.
- Conditions
- Eyelid Diseases
- Being tested
- LT2420
- Medical subject headings
- Eyelid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT2420Device
| Study group | Role | What they receive |
|---|---|---|
| device arm | Experimental | Not described Receives: Device: LT2420 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyelid DiseasesStudies 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christine Purslow, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086943
- Sponsor's protocol ID
- LT2420-PI-CE-07/07
- Status last verified
- Jan 2012
- First submitted
- 12 Mar 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01086943
- Acronym / sponsor ID
- LT2420-PI-CE-07/07
- Conditions
- Eyelid Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- First posted
- 15 Mar 2010 (estimated)
- 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 eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids.
Prospective, non comparative, open, monocentre study.
The objectives are:
- To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
- To evaluate the ocular surface, NIBUT and IOP before and after device application
- To determine the acceptability of healthy volunteers on the practical use of this device
The subjects will attend 2 visits.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| device arm | Experimental | Device: LT2420 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged from 18 to 80 years old.
- Healthy volunteers.
- For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
- Normal ocular 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 |
|---|---|---|
| LT2420 | Device | device arm |
Primary outcome
Not reported in the source record.
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 31 Jan 2012.
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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.
Christine Purslow principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LT2420 in people with Eyelid Diseases, run by Laboratoires Thea at 1 site in United Kingdom.
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 4 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 31 Jan 2012. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 31 Jan 2012.