A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Dry Eye Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Treating Dry Eye Disease Related to Meibomian Gland Dysfunction With Perfluorohexyloctane Eye Drops : A Prospective, Multicenter, Real-world Study
Обзор
Perfluorohexyloctane eye drops is the only drug in China approved for treating Dry Eye Disease (DED) related to Meibomian Gland Dysfunction (MGD), its efficacy and safety in the clinical practice of treating DED related to MGD in the real world, whether in combination with or without various other treatment methods (other drugs or physical therapy) , remain to be explored. This study aims to collect data on the treatment of DED related to MGD with perfluorohexyloctane under real medical conditions. Through analysis, it seeks to obtain clinical evidence of the product's application value and potential benefits or risks, providing evidence for the treatment of DED elated to MGD with perfluorohexyloctane under real medical conditions.
Первичные конечные точки
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Week 12]
- Incidence of adverse events assessed by the investigator as related to the study drug [Срок оценки: Week 12]
- Uncorrected Visual Acuity [UCVA] [Срок оценки: Week 12]
- Intraocular Pressure [IOP] [Срок оценки: Week 12]
- Fundus Examination Findings [Срок оценки: Week 12]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12 [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (9)
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12 [Срок оценки: Baseline and Week 12]
- Change in Inferior corneal fluorescein staining score (iCFS) at week 12 [Срок оценки: Baseline and Week 12]
- Change in Sodium fluorescein tear film break-up time (FBUT) at week 12 [Срок оценки: Baseline and Week 12]
- Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12 [Срок оценки: Baseline and Week 12]
- Change in Meibomian Gland Secretion Quality Score at Week 12 [Срок оценки: Baseline and Week 12]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 8 [Срок оценки: At baseline and week 8]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 4 [Срок оценки: At baseline and week 4]
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 8 [Срок оценки: Baseline and Week 8]
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 4 [Срок оценки: Baseline and Week 4]
Критерии участия
Критерии включения
- Patients who meet the diagnostic criteria for meibomian gland dysfunction (MGD) as stipulated in the "Expert Consensus on Diagnosis and Treatment of Meibomian Gland Dysfunction in China (2023)"
- Patients who meet the diagnostic criteria for dry eye as stipulated in the "Clinical Expert Consensus on Dry Eye in China (2020)"
- Be at least 18 years old.
- Voluntarily participate in this study and sign a written informed consent form.
Критерии исключения
- Patients who have a history of allergy to any component of the drugs or tests intended for use in the study (such as perfluorohexyloctane, fluorescein);
- Patients who used perfluorohexyloctane eye drops within 2 weeks before enrollment;
- Patients who have participated in or are currently participating in clinical trials of other drugs or devices within one month;
- Situations where researchers determine that may pose significant risks to patients, confuse the trial results, or seriously interfere with patients' participation in the trial (including language barriers).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Xiamen Eye Center Affiliated to Xiamen University — Xiamen
Идентификаторы
NCT: NCT07457021 · MA-OP-RWS-001