Stevens-Johnson SyndromeNCT05145959
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
A study testing Maskin Probe in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolyses, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN. The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses, Ocular Surface Disease
- What is being tested?
- Maskin Probe
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Mar 2024
- 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
- Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
- Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
- Patients must have evidence of Meibomitis
- Patients must be adults (18 years of age or older)
Who cannot join
- Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
- Patients beyond the sub-acute phase of SJS
- Patients without evidence of Meibomitis (See above criteria)
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear Hospital
Boston, Massachusetts, 02114
Catherine Liu, MD, 617-523-7900, CLiu54@MEEI.Harvard.edu
Hajirah Saeed, MD, MPH
About this study
The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN.
The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up.
Read more
The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.
The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.
- Conditions
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses, Ocular Surface Disease, Meibomitis, Meibomian Gland Dysfunction, Dry Eye
- Being tested
- Maskin Probe
- Keywords
- Stevens-Johnson Syndrome
- Medical subject headings
- Stevens-Johnson Syndrome, Meibomitis, Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maskin ProbeDevice
The eyelids are examined using meibography to evaluate which eyelids are more severe (right or left). A drop of proparacaine 0.5% solution is added and a bandage contact lens is placed. To avoid patient discomfort, anesthetic ointment is instilled using a sterile cotton-tipped applicator. In some cases, 4% lidocaine can be directly applied to the lid margin. The Maskin probe will be passed through the gland orifice perpendicular to the lid margin. After first using a 1-mm probe, a 2- or 4-mm probes may be used in cases of persistent resistance. The BCL is removed and the eyes are rinsed with sterile preservative-free saline. The patient is given preservative-free artificial tears to use every hour. A brief slit lamp exam will performed in order to ensure that there is no unanticipated damage to the lid or cornea. The probing device will be properly disposed of in the sharps containers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian gland imaging (Meibography) - Qualitative description
To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.
Measured: 6 months
Secondary outcomes (1)
Ocular Surface Disease Index survey
The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson SyndromeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajirah N. Saeed, M.D., Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145959
- Sponsor's protocol ID
- 2020P000608
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
- ClinicalTrials.gov ID
- NCT05145959
- Acronym / sponsor ID
- 2020P000608
- Conditions
- Stevens-Johnson Syndrome, Toxic Epidermal Necrolyses, Ocular Surface Disease, Meibomitis, Meibomian Gland Dysfunction, Dry Eye
- Keywords
- Stevens-Johnson Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 Dec 2021 (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 investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN.
The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up.
The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.
The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
- Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
- Patients must have evidence of Meibomitis
- Patients must be adults (18 years of age or older)
Key exclusion criteria (4 listed)
- Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
- Patients beyond the sub-acute phase of SJS
- Patients without evidence of Meibomitis (See above criteria)
- Patients under the age of 18
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 |
|---|---|---|
| Maskin ProbeThe eyelids are examined using meibography to evaluate which eyelids are more severe (right or left). A drop of proparacaine 0.5% solution is added and a bandage contact lens is placed. To avoid patient discomfort, anesthetic ointment is instilled using a sterile cotton-tipped applicator. In some cases, 4% lidocaine can be directly applied to the lid margin. The Maskin probe will be passed through the gland orifice perpendicular to the lid margin. After first using a 1-mm probe, a 2- or 4-mm probes may be used in cases of persistent resistance. The BCL is removed and the eyes are rinsed with sterile preservative-free saline. The patient is given preservative-free artificial tears to use every hour. A brief slit lamp exam will performed in order to ensure that there is no unanticipated damage to the lid or cornea. The probing device will be properly disposed of in the sharps containers. | Device | – |
Primary outcome
Meibomian gland imaging (Meibography) - Qualitative description
Time frame: 6 months
To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.
1 secondary outcome
Ocular Surface Disease Index survey
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maskin Probe in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolyses, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2021. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Liu, MD (617-523-7900, CLiu54@MEEI.Harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian gland imaging (Meibography) - Qualitative description (time frame: 6 months). 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 6 Dec 2021.