Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome

Not Applicable

Completed

• Conditions: Sjögren's Syndrome Patients With Severe Dry Eye
• Interventions: 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

• Registration Number: NCT02147509
• Lead Sponsor: Jinyang Li

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-20
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe dry eye	0.02% Fm, SH, tBCL	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)
Severe dry eye	0.02% Fm, SH, AS	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)
Severe dry eye	0.02% Fm, SH	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)
Severe dry eye	0.02% Fm, SH, 0.05% CsA	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)

Primary Outcome Measures

Name	Time	Method
C Corneal fluorescein staining	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

Secondary Outcome Measures

Name	Time	Method
Tear film breakup time	up to 12 weeks	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
quality of the life	up to 12 weeks	tested by The Medical Outcomes Study 36-Item Short-Form Health Survey
Symptom of the dryness	up to 12 weeks	Tested by ocular surface disease index
Visual acuity	up to 12 weeks	statistical analysis by logMAR.
Schirmer I test	up to 12 weeks	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.

Trial Locations

Locations (1)

Eye Hospital, Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China