NCT07298811已完成1 期
Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease: a Randomized, Single-blind,-Controlled Trial.
Second Affiliated Hospital of Nanchang University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Score on the Visual Analog Scale (VAS) for Ocular Discomfort
研究概览
简要总结
Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.
详细描述
Evaluate the efficacy and safety of ocular surface microbiota transplantation as an adjunctive therapy for dry eye, and explore its impact on the structure of the ocular surface microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 是
入选标准
- •for patients with moderate-to-severe DED were as follows: (1) age 18-70 years, regardless of sex; (2) a diagnosis of DED based on the 2016 Asian Dry Eye Society guidelines and the TFOS DEWS II criteria. Moderate-to-severe DED was defined as meeting the DED diagnostic criteria and having at least one of the following: an OSDI score ≥23 (indicating symptomatic dry eye), FBUT ≤5 s, or Schirmer I test ≤5 mm/5 min; (3) willingness and ability to comply with routine treatment and OSM transplantation during the study period. (4) Voluntary participation in this clinical study and provision of written informed consent.
排除标准
- •were as follows: (1) history of chronic diseases; (2) current or previous eyelid, conjunctival, or lacrimal duct disease; (3) history of ocular surgery or contact lens wear; (4) concurrent active infection of the eye or other systemic sites; (5) history of recurrent viral keratitis or the presence of significant neurotrophic keratitis; (6) use of systemic medications within the past 2 months; (7) severe organ disease; (8) immunodeficiency; (9) participation in another clinical trial within the past month or current participation in another clinical trial; (10) allergy to any component of the study device or study reagents; (11) chronic use of medications or probiotic-containing supplements; (12) unhealthy lifestyle habits or environmental factors (e.g., smoking or alcohol abuse); (13) any other conditions considered incompatible with the study.
- •Healthy donor inclusion criteria were as follows: (1) Age 18-50 years; (2) The donor for OSM transplantation was a family member of the recipient and had a consanguineous (biological) relationship with the recipient; (3) Normal structure and function of the ocular surface, no ocular diseases or related symptoms, and normal visual function. Exclusion criteria were as follows: (1) infectious diseases such as HIV or hepatitis B; (2) potential viral or other infections of the ocular surface; (3) current or previous eyelid, conjunctival, or lacrimal duct disease; (4) use of systemic medications, antibiotics, herbal medicines, or probiotics within the past 1 month; (5) pregnancy or any other condition that may affect the study results.
研究组 & 干预措施
ocular surface microbiota transplantation group
Active Comparator
Transplant operation to dry eye patients
干预措施: Ocular surface microbiota transplantation (Biological)
placebo transplantation group
Placebo Comparator
placebo transplantation to dry eye patients
干预措施: placebo transplantation Group (Biological)
结局指标
主要结局
Score on the Visual Analog Scale (VAS) for Ocular Discomfort
时间窗: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.
The severity of ocular discomfort (e.g., dryness, pain) is assessed using a 100-mm Visual Analog Scale (VAS). Participants mark their level of discomfort on a line from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The score is the distance measured in millimeters (mm). A higher score indicates more severe symptoms (worse outcome).
次要结局
- Corneal Fluorescein Staining Score (using the NEI scale)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Change in conjunctival sac microbiota composition assessed by 16S rRNA gene sequencing(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Result of Schirmer I Test (without anesthesia)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Tear Film Break-Up Time (TBUT)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Change in tear fluid inflammatory cytokine levels(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Score on the Ocular Surface Disease Index (OSDI) Questionnaire(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Total Corneal Fluorescein Staining (tCFS)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Schirmer I Test(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
- Fluorescein Break-Up Time (FBUT)(At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.)
研究者
Yifeng Yu
Associate Chief Physician, Ph.D.
Second Affiliated Hospital of Nanchang University
研究点 (2)
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