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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02147509
• Date of registration: 13/05/2014
• Prospective Registration: No
• Primary sponsor: Jinyang Li
• Public title: Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome BCL
• Scientific title: Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
• Date of first enrolment: March 2013
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02147509
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Jinyang Li, MD,PhD
• Affiliation: Eye Hospital, Wenzhou Medical College, China

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sjögren's Syndrome Patients With Severe Dry Eye

Intervention(s)

Drug: 0.02% Fm, SH

Drug: 0.02% Fm, SH, AS

Other: 0.02% Fm, SH, tBCL

Drug: 0.02% Fm, SH, 0.05% CsA

Primary Outcome(s)

C Corneal fluorescein staining [Time Frame: up to 12 weeks]

Secondary Outcome(s)

Symptom of the dryness [Time Frame: up to 12 weeks]

Schirmer I test [Time Frame: up to 12 weeks]

quality of the life [Time Frame: up to 12 weeks]

Tear film breakup time [Time Frame: up to 12 weeks]

Visual acuity [Time Frame: up to 12 weeks]

Secondary ID(s)

BCL-018-SS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors