Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Ocular surface microbiota transplantation
  Ocular surface microbiota transplantation
• Биопрепарат Placebo Group
  Fake transplant operation

Первичные конечные точки

• Score on the Visual Analog Scale (VAS) for Ocular Discomfort [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]

Вторичные конечные точки (6)

• Corneal Fluorescein Staining Score (using the NEI scale) [Срок оценки: 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 [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]
• Result of Schirmer I Test (without anesthesia) [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]
• Tear Film Break-Up Time (TBUT) [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]
• Score on the Ocular Surface Disease Index (OSDI) Questionnaire [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]
• Change in tear fluid inflammatory cytokine levels [Срок оценки: At baseline (pre-intervention), and at 1 week, 2 weeks, and 4 weeks post-intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Yifeng Yu — Nanchang

Идентификаторы

NCT: NCT07298811 · IIT-I-2025-081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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