Treating Dry Eye Disease Related to Meibomian Gland Dysfunction With Perfluorohexyloctane Eye Drops : A Prospective, Multicenter, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Week 12
Incidence of adverse events assessed by the investigator as related to the study drug
时间窗: Week 12
Uncorrected Visual Acuity [UCVA]
时间窗: Week 12
Visual acuity will be assessed without any refractive correction using the Standard Logarithmic Visual Acuity Chart and scored as the LogMAR value. The measurement will be taken for each eye separately.
Intraocular Pressure [IOP]
时间窗: Week 12
Intraocular pressure will be measured using Goldmann Applanation Tonometer (GAT) and recorded in millimeters of mercury (mmHg). Each measurement will be performed three times\] per eye and the average value will be used for analysis.
Fundus Examination Findings
时间窗: Week 12
Fundus examination will be performed under small pupil conditions using direct ophthalmoscopy or indirect ophthalmoscopy. The examination will assess the optic disc, macula, retinal vessels, and peripheral retina . Findings will be documented descriptively.
Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12
时间窗: Baseline and Week 12
Mean change from baseline in the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire total score. The SPEED assesses the frequency and severity of dry eye symptoms (dryness, grittiness, soreness, burning). The total score ranges from 0 to 28, with higher scores indicating more severe symptoms.
次要结局
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12(Baseline and Week 12)
- Change in Inferior corneal fluorescein staining score (iCFS) at week 12(Baseline and Week 12)
- Change in Sodium fluorescein tear film break-up time (FBUT) at week 12(Baseline and Week 12)
- Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12(Baseline and Week 12)
- Change in Meibomian Gland Secretion Quality Score at Week 12(Baseline and Week 12)
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 8(At baseline and week 8)
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 4(At baseline and week 4)
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 8(Baseline and Week 8)
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 4(Baseline and Week 4)