Cicatrizing ConjunctivitisNCT03839069
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
A study testing minor salivary gland transplantation in people with Cicatrizing Conjunctivitis and Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome
- What is being tested?
- minor salivary gland transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2016to Jun 2021
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20-85 years old
- unilateral or bilateral cicatrizing conjunctivitis
- severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)
- chronic ocular surface disease score (COCS) over 3 points
- Oxford scheme over grade III
Who cannot join
- active ocular infection
- active corneal melting
- severe xerostomia (modified Schirmer I test result of less than 25mm)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 10002
Hsiao Sang Chu, MD,MS, +886-2-23123456 ext. 63804, stephaniechu@ntuh.gov.tw
About this study
Official title: The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.
Read the detailed description
Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction.
This study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. The investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.
- Conditions
- Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome, Mucous Membrane Pemphigoid, Chronic Graft Versus Host Disease, Chemical Burn to Eye
- Being tested
- minor salivary gland transplantation
- Medical subject headings
- Stevens-Johnson Syndrome, Sjogren's Syndrome, Pemphigoid, Benign Mucous Membrane, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minor salivary gland transplantationProcedure or surgery
The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.
| Study group | Role | What they receive |
|---|---|---|
| Minor Salivary Gland Transplantation | Experimental | Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment. Receives: Procedure: minor salivary gland transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.
Measured: the Schirmer's test will be performed every three months until 12 months after operation
the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.
Measured: the OSDI will be monitored every three months until 12 months
the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.
Measured: the COCS will be monitored every three months until 12 months after operation
Secondary outcomes (1)
the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.
Measured: the impression cytology will be performed every three months until 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startSep 2016
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatrizing ConjunctivitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Sang Chu, MD, MS, Principal investigator, Department of Ophthalmology, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839069
- Sponsor's protocol ID
- 201503027DINB
- Status last verified
- Jan 2019
- First submitted
- 31 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: for research purpose only
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis
- ClinicalTrials.gov ID
- NCT03839069
- Acronym / sponsor ID
- 201503027DINB
- Conditions
- Cicatrizing Conjunctivitis, Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, Sjogren Syndrome, Mucous Membrane Pemphigoid, Chronic Graft Versus Host Disease, Chemical Burn to Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 15 Feb 2019 (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.
This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.
Detailed description
Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction.
This study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. The investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minor Salivary Gland Transplantation | Experimental | Procedure: minor salivary gland transplantationCicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 20-85 years old
- unilateral or bilateral cicatrizing conjunctivitis
- severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)
- chronic ocular surface disease score (COCS) over 3 points
- Oxford scheme over grade III
Key exclusion criteria (3 listed)
- active ocular infection
- active corneal melting
- severe xerostomia (modified Schirmer I test result of less than 25mm)
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 |
|---|---|---|
| minor salivary gland transplantationThe investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye. | Procedure or surgery | Minor Salivary Gland Transplantation |
Primary outcome
the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
Time frame: the Schirmer's test will be performed every three months until 12 months after operation
to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.
the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
Time frame: the OSDI will be monitored every three months until 12 months
to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.
the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
Time frame: the COCS will be monitored every three months until 12 months after operation
to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.
1 secondary outcome
the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
Time frame: the impression cytology will be performed every three months until 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No. for research purpose only
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.
Hsiao-Sang Chu, MD, MS principal investigator
Department of Ophthalmology, NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minor salivary gland transplantation in people with Cicatrizing Conjunctivitis and Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 15 Feb 2019. 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 Taiwan. 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 Hsiao-Sang Chu, MD, MS (+886-2-23123456 ext. 63804, stephaniechu@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation (time frame: the Schirmer's test will be performed every three months until 12 months after operation). 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 15 Feb 2019.