Sjögren's Syndrome Patients With Severe Dry EyeBCLNCT02147509
Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome
A study testing 0.02% Fm, SH, 0.02% Fm, SH, 0.05% CsA and 0.02% Fm, SH, tBCL in people with Sjögren's Syndrome Patients With Severe Dry Eye, run by Jinyang Li at 1 site in China.
Trial summary
The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic bandage contact lenses treating dry eye caused by Sjögren's syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjögren's Syndrome Patients With Severe Dry Eye
- What is being tested?
- 0.02% Fm, SH, 0.02% Fm, SH, 0.05% CsA and 0.02% Fm, SH, tBCL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Apr 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: male or female between 18~70 years old without wearing contact lens.
- Diagnosis and classification: all patients should have the symptoms and signs of severe dry eye (conforming to grade 3 or 4 in DEWS2007). Should have at least two positive symptoms such as dryness, foreign body sensation, burning, asthenopia, red eye or secretion. Tear film breakup time (TFBUT) shorter than 5 seconds and/or Schirmer I less than 5 mm/5 min. Corneal fluorescein staining more than 6 scores and (or) more than 3 scores of bulbar conjunctiva lissamine green liquor.
- Both eyes of all patients were preliminarily examined, the patients with single eye that meets the criterion were also investigated. Objective indicators were investigated on each eye. While the ocular surface disease index (OSDI) scores and SF-36 results were evaluated on an individual base.
- All patients should not participate in other medical tests in the past 2 weeks.
- Should either not be treated with other medicine at present, or have been treated with other medicine but had paused more than 2 weeks
Who cannot join
- Pregnant or maternity: exclude the patients who are or will be pregnant or during breast feeding.
- Other surface diseases: exclude the patients who are suspected or complicated by other obvious ocular surface diseases.
- Severe systemic diseases: exclude the patients with severe primary diseases in heart, brain blood vessel, liver, kidney, hematopoietic system and so on.
- Intraocular surgery or trauma: exclude the patients with intraocular surgery or trauma during 6 months.
- Hormone replacement therapy : exclude post-menopausal women who are treated in hormone replacement therapy.
- Lacrimal punctum: exclude the patients who have been treated with lacrimal punctum in 1 month.
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- Glaucoma or high IOP: exclude the patients who have glaucoma or high intraocular pressure (IOP) sores.
- Exclude the patients who are sensitive to steroid.
- Exclude the patients who can't wear the therapeutic bandage contact lens during the clinical study.
- Immunosuppressive therapies: exclude the patients who are using systemic steroid or immunosuppressive therapies which may influent the results of the evaluation of the therapeutic effect.
- Excluding the patients who may not be suitable for the clinical examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic bandage contact lenses treating dry eye caused by Sjögren's syndrome.
Read the detailed description
Comparisons were made between Sjögren's syndrome patients with severe dry eye on the subjective and objective therapeutic effects of the overnight therapeutic bandage contact lenses at different period (i.e. before wearing, after wearing 3 weeks, after another 3 weeks with new lens and after 6 weeks without wearing ) based on the results of examinations.
- Being tested
- 0.02% Fm, SH, 0.02% Fm, SH, 0.05% CsA, 0.02% Fm, SH, tBCL, 0.02% Fm, SH, AS
- Keywords
- Dry eye, Therapeutic bandage contact lenses, The quality of life
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.02% Fm, SHDrug
Also called baseline treatment
Sjogren's Syndrome patients with severe dry eye
0.02% Fm, SH, 0.05% CsADrug
Also called immunosuppression treatment
Sjogren's Syndrome patients with severe dry eye
0.02% Fm, SH, tBCLOther
Also called BCL treatment
Sjogren's Syndrome patients with severe dry eye
0.02% Fm, SH, ASDrug
Also called Autologous Serum Treatment
Sjogren's Syndrome patients with severe dry eye
| Study group | Role | What they receive |
|---|---|---|
| Severe dry eye | Experimental | 1. 0.02% Fm, SH
2. 0.02% Fm, SH, AS
3. 0.02% Fm, SH, 0.05% CsA
4. 0.02% Fm, SH, tBCL (0.05% CsA: 0.05% cyclosporin A; tBCL: therapeutic bandage contact lenses; 0.02% Fm: 0.02% Fluorometholone; AS: Autologous Serum; SH: Sodium Hyaluronate) Receives: Drug: 0.02% Fm, SH; Drug: 0.02% Fm, SH, 0.05% CsA; Other: 0.02% Fm, SH, tBCL; Drug: 0.02% Fm, SH, AS |
What is being measured
The primary outcome is the main question the study is designed to answer.
C Corneal fluorescein staining
Divide the corneal into 4 quadrants and score each quadrant:
0 score-no stains
- score-between 1 and 3 spots stained
- scores-greater than or equal 4 spots stained
- scores-spots stained fusion or filamentary
Measured: up to 12 weeks
Secondary outcomes (5)
Visual acuity
statistical analysis by logMAR.
Measured: up to 12 weeks
Tear film breakup time
The lower fornix was stained with fluorescein paper, after the patient blinked a couple of times, the length of time between the last blink and tear BUT was recorded in seconds using a biomicroscope with cobalt blue lightning
Measured: up to 12 weeks
Schirmer I test
standard Schirmer paper (5 mm width x 35 mm length) was placed at the intersection point of the lateral and middle one-third quadrants of the lower eye lid without anesthesia,and the wetting level was recorded in mm after 5 minThe operation is completed in the same laboratory.
Measured: up to 12 weeks
quality of the life
tested by The Medical Outcomes Study 36-Item Short-Form Health Survey
Measured: up to 12 weeks
Symptom of the dryness
Tested by ocular surface disease index
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjögren's Syndrome Patients With Severe Dry EyeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinyang Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinyang Li, Wenzhou Medical University
- Investigators
- Jinyang Li, MD,PhD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147509
- Sponsor's protocol ID
- BCL-018-SS
- Acronym
- BCL
- Status last verified
- Jul 2014
- First submitted
- 13 May 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li J, Zhang X, Zheng Q, Zhu Y, Wang H, Ma H, Jhanji V, Chen W. Comparative Evaluation of Silicone Hydrogel Contact Lenses and Autologous Serum for Management of Sjogren Syndrome-Associated Dry Eye. Cornea. 2015 Sep;34(9):1072-8. doi: 10.1097/ICO.0000000000000515.
PubMed 26147835
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT02147509
- Acronym / sponsor ID
- BCL / BCL-018-SS
- Keywords
- Dry eye, Therapeutic bandage contact lenses, The quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Jinyang LiUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 May 2014 (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 purpose of this study is to evaluate the therapeutic effect and safety of therapeutic bandage contact lenses treating dry eye caused by Sjögren's syndrome.
Detailed description
Comparisons were made between Sjögren's syndrome patients with severe dry eye on the subjective and objective therapeutic effects of the overnight therapeutic bandage contact lenses at different period (i.e. before wearing, after wearing 3 weeks, after another 3 weeks with new lens and after 6 weeks without wearing ) based on the results of examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe dry eye | Experimental | Drug: 0.02% Fm, SH, Drug: 0.02% Fm, SH, 0.05% CsA, Other: 0.02% Fm, SH, tBCL, Drug: 0.02% Fm, SH, AS1. 0.02% Fm, SH 2. 0.02% Fm, SH, AS 3. 0.02% Fm, SH, 0.05% CsA 4. 0.02% Fm, SH, tBCL (0.05% CsA: 0.05% cyclosporin A; tBCL: therapeutic bandage contact lenses; 0.02% Fm: 0.02% Fluorometholone; AS: Autologous Serum; SH: Sodium Hyaluronate) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Gender: male or female between 18~70 years old without wearing contact lens.
- Diagnosis and classification: all patients should have the symptoms and signs of severe dry eye (conforming to grade 3 or 4 in DEWS2007). Should have at least two positive symptoms such as dryness, foreign body sensation, burning, asthenopia, red eye or secretion. Tear film breakup time (TFBUT) shorter than 5 seconds and/or Schirmer I less than 5 mm/5 min. Corneal fluorescein staining more than 6 scores and (or) more than 3 scores of bulbar conjunctiva lissamine green liquor.
- Both eyes of all patients were preliminarily examined, the patients with single eye that meets the criterion were also investigated. Objective indicators were investigated on each eye. While the ocular surface disease index (OSDI) scores and SF-36 results were evaluated on an individual base.
- All patients should not participate in other medical tests in the past 2 weeks.
- Should either not be treated with other medicine at present, or have been treated with other medicine but had paused more than 2 weeks
Key exclusion criteria (11 listed)
- Pregnant or maternity: exclude the patients who are or will be pregnant or during breast feeding.
- Other surface diseases: exclude the patients who are suspected or complicated by other obvious ocular surface diseases.
- Severe systemic diseases: exclude the patients with severe primary diseases in heart, brain blood vessel, liver, kidney, hematopoietic system and so on.
- Intraocular surgery or trauma: exclude the patients with intraocular surgery or trauma during 6 months.
- Hormone replacement therapy : exclude post-menopausal women who are treated in hormone replacement therapy.
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 |
|---|---|---|
| 0.02% Fm, SHAlso: baseline treatmentSjogren's Syndrome patients with severe dry eye | Drug | Severe dry eye |
| 0.02% Fm, SH, 0.05% CsAAlso: immunosuppression treatmentSjogren's Syndrome patients with severe dry eye | Drug | Severe dry eye |
| 0.02% Fm, SH, tBCLAlso: BCL treatmentSjogren's Syndrome patients with severe dry eye | Other | Severe dry eye |
| 0.02% Fm, SH, ASAlso: Autologous Serum TreatmentSjogren's Syndrome patients with severe dry eye | Drug | Severe dry eye |
Primary outcome
C Corneal fluorescein staining
Time frame: up to 12 weeks
Divide the corneal into 4 quadrants and score each quadrant: 0 score-no stains 1. score-between 1 and 3 spots stained 2. scores-greater than or equal 4 spots stained 3. scores-spots stained fusion or filamentary
5 secondary outcomes
Visual acuity
Time frame: up to 12 weeks
Tear film breakup time
Time frame: up to 12 weeks
Schirmer I test
Time frame: up to 12 weeks
quality of the life
Time frame: up to 12 weeks
Symptom of the dryness
Time frame: up to 12 weeks
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 22 Jul 2014.
- Derived from this study: PubMed 26147835Li J, Zhang X, Zheng Q, Zhu Y, Wang H, Ma H, Jhanji V, Chen W. Comparative Evaluation of Silicone Hydrogel Contact Lenses and Autologous Serum for Management of Sjogren Syndrome-Associated Dry Eye. Cornea. 2015 Sep;34(9):1072-8. doi: 10.1097/ICO.0000000000000515.
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.
Jinyang Li, MD,PhD principal investigator
Eye Hospital, Wenzhou Medical College, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.02% Fm, SH, 0.02% Fm, SH, 0.05% CsA and 0.02% Fm, SH, tBCL in people with Sjögren's Syndrome Patients With Severe Dry Eye, run by Jinyang Li at 1 site in China.
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 11 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 22 Jul 2014. 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 China. 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?
C Corneal fluorescein staining (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147509, which also lists 1 linked publication.
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 22 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.