Sjögren's Syndrome Patients With Severe Dry Eye Clinical Trial
— BCLOfficial title:
Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
| Verified date | July 2014 |
| Source | Wenzhou Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Eye Hospital, Wenzhou Medical College | Wenzhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Jinyang Li |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Bulbar conjunctiva lissamine green staining | 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 |
up to 12 weeks | No |
| Primary | 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 |
up to 12 weeks | Yes |
| Secondary | Visual acuity | statistical analysis by logMAR. | up to 12 weeks | Yes |
| Secondary | 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 | up to 12 weeks | No |
| Secondary | 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. | up to 12 weeks | No |
| Secondary | quality of the life | tested by The Medical Outcomes Study 36-Item Short-Form Health Survey | up to 12 weeks | No |
| Secondary | Symptom of the dryness | Tested by ocular surface disease index | up to 12 weeks | No |