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

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.

Study Overview

• Status: Completed
• Conditions: Sjögren's Syndrome Patients With Severe Dry Eye
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hospital, Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Severe dry eye; 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)

Drug: 0.02% Fm, SH; Sjogren's Syndrome patients with severe dry eye; Other Names: baseline treatment; Drug: 0.02% Fm, SH, 0.05% CsA; Sjogren's Syndrome patients with severe dry eye; Other Names: immunosuppression treatment; Other: 0.02% Fm, SH, tBCL; Sjogren's Syndrome patients with severe dry eye; Other Names: BCL treatment; Drug: 0.02% Fm, SH, AS; Sjogren's Syndrome patients with severe dry eye; Other Names: Autologous Serum Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	statistical analysis by logMAR.	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	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.	up to 12 weeks
quality of the life	tested by The Medical Outcomes Study 36-Item Short-Form Health Survey	up to 12 weeks
Symptom of the dryness	Tested by ocular surface disease index	up to 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jinyang Li
• Investigators: Principal Investigator: Jinyang Li, MD,PhD, Eye Hospital, Wenzhou Medical College, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Estimate): July 22, 2014
• Last Update Submitted That Met QC Criteria: July 20, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Dry eye; Therapeutic bandage contact lenses; The quality of life
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: BCL-018-SS