Clinical trial NCT02147509: Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome
Official title: Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjögren's Syndrome Patients With Severe Dry Eye
Keywords: Dry eye
Therapeutic bandage contact lenses
The quality of life
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: C Corneal fluorescein staining
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Visual acuity
timeFrame: up to 12 weeks
measure: Tear film breakup time
timeFrame: up to 12 weeks
measure: Schirmer I test
timeFrame: up to 12 weeks
measure: quality of the life
timeFrame: up to 12 weeks
measure: Symptom of the dryness
timeFrame: up to 12 weeks
Other outcomes:
measure: Bulbar conjunctiva lissamine green staining
timeFrame: up to 12 weeks
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Jinyang Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.