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.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 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
- •Dry Eye Patient Group:
- •Aged 18 to 70 years, male or female.
- •Meets the diagnostic criteria for moderate to severe mixed dry eye according to the Expert Consensus on Dry Eye (2020), including:
- •At least one subjective symptom (e.g., dryness, foreign body sensation, burning, fatigue, discomfort, redness, or vision fluctuation).
- •Fluorescein tear film break-up time (FBUT) ≤ 5 seconds.
- •Willing and able to actively cooperate with the prescribed course of standard dry eye medications and ocular surface microbiota transplantation therapy for the study duration.
- •Voluntarily agrees to participate and signs the informed consent form.
- •Healthy Donor Group:
- •A family member of a participating subject.
- •Aged 18 to 50 years.
- •Normal ocular surface structure and function, with no ocular diseases or related symptoms, and good visual function.
排除标准
- •Dry Eye Patient Group:
- •History of systemic chronic diseases (e.g., uncontrolled diabetes, autoimmune disorders).
- •Current or past history of eyelid abnormalities, conjunctival disease, or lacrimal duct obstruction.
- •History of any ocular surgery or regular wear of corneal contact lenses.
- •Active infection in the eye(s) or any other part of the body.
- •History of multiple episodes of viral keratitis or presence of significant neurotrophic keratitis.
- •Any other condition deemed by the investigator to be unsuitable for participation.
- •Healthy Donor Group:
- •Known infectious diseases (e.g., HIV, Hepatitis B).
- •Signs or symptoms suggestive of active ocular surface infection or other viral infections.
- •Current or past history of eyelid, conjunctival, or lacrimal duct diseases.
- •Use of systemic medications (including antibiotics), traditional Chinese herbal medicine, or probiotic supplements within 1 month prior to screening.
- •Pregnancy, lactation, or any other condition that may potentially affect the study outcomes.
研究组 & 干预措施
Transplant group
Transplant operation to dry eye patients
干预措施: Ocular surface microbiota transplantation (Biological)
Placebo group
Fake transplantation to dry eye patients
干预措施: Placebo 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.)
- Score on the Ocular Surface Disease Index (OSDI) Questionnaire(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.)
研究者
Yifeng Yu
Associate Chief Physician, Ph.D.
Second Affiliated Hospital of Nanchang University