NCT02147509已完成不适用
Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
Jinyang Li1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- C Corneal fluorescein staining
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Severe dry eye
Experimental
- 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)
干预措施: 0.02% Fm, SH (Drug)
Severe dry eye
Experimental
- 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)
干预措施: 0.02% Fm, SH, 0.05% CsA (Drug)
Severe dry eye
Experimental
- 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)
干预措施: 0.02% Fm, SH, tBCL (Other)
Severe dry eye
Experimental
- 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)
干预措施: 0.02% Fm, SH, AS (Drug)
结局指标
主要结局
C Corneal fluorescein staining
时间窗: 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
次要结局
- Tear film breakup time(up to 12 weeks)
- quality of the life(up to 12 weeks)
- Symptom of the dryness(up to 12 weeks)
- Visual acuity(up to 12 weeks)
- Schirmer I test(up to 12 weeks)
研究者
Jinyang Li
Eye Hospital
Wenzhou Medical University
研究点 (1)
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