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

Jinyang Li

Status: Completed

Conditions: Sjögren's Syndrome Patients With Severe Dry Eye

Treatments: Drug: 0.02% Fm, SH, AS; Drug: 0.02% Fm, SH; Drug: 0.02% Fm, SH, 0.05% CsA; Other: 0.02% Fm, SH, tBCL

Study type: Interventional

Funder types: Other

Identifiers

NCT02147509

BCL-018-SS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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64 participants in 1 patient group

Severe dry eye

Experimental group

Description:

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)

Treatment:

Other: 0.02% Fm, SH, tBCL

Drug: 0.02% Fm, SH, 0.05% CsA

Drug: 0.02% Fm, SH

Drug: 0.02% Fm, SH, AS