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

NCT ID: NCT02147509

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Sjögren's Syndrome Patients With Severe Dry Eye

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

0.02% Fm, SH

Intervention Type: DRUG

Sjogren's Syndrome patients with severe dry eye

0.02% Fm, SH, 0.05% CsA

Intervention Type: DRUG

Sjogren's Syndrome patients with severe dry eye

0.02% Fm, SH, tBCL

Intervention Type: OTHER

Sjogren's Syndrome patients with severe dry eye

0.02% Fm, SH, AS

Intervention Type: DRUG

Sjogren's Syndrome patients with severe dry eye

Interventions

0.02% Fm, SH

Sjogren's Syndrome patients with severe dry eye

Intervention Type: DRUG

0.02% Fm, SH, 0.05% CsA

Sjogren's Syndrome patients with severe dry eye

Intervention Type: DRUG

0.02% Fm, SH, tBCL

Sjogren's Syndrome patients with severe dry eye

Intervention Type: OTHER

0.02% Fm, SH, AS

Sjogren's Syndrome patients with severe dry eye

Intervention Type: DRUG

Other Intervention Names

baseline treatment; immunosuppression treatment; BCL treatment; Autologous Serum Treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinyang Li

OTHER

Sponsor Role: lead

Responsible Party

Jinyang Li

Eye Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jinyang Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital, Wenzhou Medical College, China

Locations

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26147835 (View on PubMed)

Other Identifiers

BCL-018-SS

Identifier Type: -

Identifier Source: org_study_id