Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02147509
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Jinyang Li, Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Patients With Severe Dry Eye 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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
Study Start Date : March 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Severe dry eye
  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)
Drug: 0.02% Fm, SH
Sjogren's Syndrome patients with severe dry eye
Other Name: baseline treatment

Drug: 0.02% Fm, SH, 0.05% CsA
Sjogren's Syndrome patients with severe dry eye
Other Name: immunosuppression treatment

Other: 0.02% Fm, SH, tBCL
Sjogren's Syndrome patients with severe dry eye
Other Name: BCL treatment

Drug: 0.02% Fm, SH, AS
Sjogren's Syndrome patients with severe dry eye
Other Name: Autologous Serum Treatment




Primary Outcome Measures :
  1. C Corneal fluorescein staining [ Time Frame: 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 :
  1. Visual acuity [ Time Frame: up to 12 weeks ]
    statistical analysis by logMAR.

  2. Tear film breakup time [ Time Frame: 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

  3. Schirmer I test [ Time Frame: 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.

  4. quality of the life [ Time Frame: up to 12 weeks ]
    tested by The Medical Outcomes Study 36-Item Short-Form Health Survey

  5. Symptom of the dryness [ Time Frame: up to 12 weeks ]
    Tested by ocular surface disease index


Other Outcome Measures:
  1. Bulbar conjunctiva lissamine green staining [ Time Frame: up to 12 weeks ]

    Divide the bulbar conjunctiva into 3 quadrants and score each quadrant:

    0 score-no stain

    1. score-between 1 and 3 spots stained
    2. scores-greater than or equal 4 spots stained
    3. scores-spots stained fusion or filamentary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147509


Locations
Layout table for location information
China, Zhejiang
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Jinyang Li
Investigators
Layout table for investigator information
Principal Investigator: Jinyang Li, MD,PhD Eye Hospital, Wenzhou Medical College, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jinyang Li, Eye Hospital, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02147509     History of Changes
Other Study ID Numbers: BCL-018-SS
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Jinyang Li, Wenzhou Medical University:
Dry eye
Therapeutic bandage contact lenses
The quality of life

Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases