Back to resultsEvaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome (BCL)
Primary Purpose
Sjögren's Syndrome Patients With Severe Dry Eye
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.02% Fm, SH
0.02% Fm, SH, 0.05% CsA
0.02% Fm, SH, tBCL
0.02% Fm, SH, AS
Sponsored by
About this trial
This is an interventional treatment trial for Sjögren's Syndrome Patients With Severe Dry Eye focused on measuring Dry eye, Therapeutic bandage contact lenses, The quality of life
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Eye Hospital, Wenzhou Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Severe dry eye
Arm Description
0.02% Fm, SH 0.02% Fm, SH, AS 0.02% Fm, SH, 0.05% CsA 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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual acuity
statistical analysis by logMAR.
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
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.
quality of the life
tested by The Medical Outcomes Study 36-Item Short-Form Health Survey
Symptom of the dryness
Tested by ocular surface disease index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02147509
Brief Title
Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome
Acronym
BCL
Official Title
Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jinyang Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjögren's Syndrome Patients With Severe Dry Eye
Keywords
Dry eye, Therapeutic bandage contact lenses, The quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe dry eye
Arm Type
Experimental
Arm Description
0.02% Fm, SH
0.02% Fm, SH, AS
0.02% Fm, SH, 0.05% CsA
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)
Intervention Type
Drug
Intervention Name(s)
0.02% Fm, SH
Other Intervention Name(s)
baseline treatment
Intervention Description
Sjogren's Syndrome patients with severe dry eye
Intervention Type
Drug
Intervention Name(s)
0.02% Fm, SH, 0.05% CsA
Other Intervention Name(s)
immunosuppression treatment
Intervention Description
Sjogren's Syndrome patients with severe dry eye
Intervention Type
Other
Intervention Name(s)
0.02% Fm, SH, tBCL
Other Intervention Name(s)
BCL treatment
Intervention Description
Sjogren's Syndrome patients with severe dry eye
Intervention Type
Drug
Intervention Name(s)
0.02% Fm, SH, AS
Other Intervention Name(s)
Autologous Serum Treatment
Intervention Description
Sjogren's Syndrome patients with severe dry eye
Primary Outcome Measure Information:
Title
C Corneal fluorescein staining
Description
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
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Visual acuity
Description
statistical analysis by logMAR.
Time Frame
up to 12 weeks
Title
Tear film breakup time
Description
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
Time Frame
up to 12 weeks
Title
Schirmer I test
Description
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.
Time Frame
up to 12 weeks
Title
quality of the life
Description
tested by The Medical Outcomes Study 36-Item Short-Form Health Survey
Time Frame
up to 12 weeks
Title
Symptom of the dryness
Description
Tested by ocular surface disease index
Time Frame
up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Bulbar conjunctiva lissamine green staining
Description
Divide the bulbar conjunctiva into 3 quadrants and score each quadrant:
0 score-no stain
score-between 1 and 3 spots stained
scores-greater than or equal 4 spots stained
scores-spots stained fusion or filamentary
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyang Li, MD,PhD
Organizational Affiliation
Eye Hospital, Wenzhou Medical College, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital, Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26147835
Citation
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.
Results Reference
derived
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Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome
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