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.
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.
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).
Chinese patients with dry eye disease related to meibomian gland dysfunction who use perfluorohexyloctane eye drops
Cohort
Prospective
Not listed
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of adverse events assessed by the investigator as related to the study drug
Uncorrected Visual Acuity [UCVA]
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]
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.
Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12
Mean change from baseline in total corneal fluorescein staining score (tCFS), assessed using the modified National Eye Institute (NEI) scale. The cornea is divided into 5 regions (central, superior, inferior, nasal, temporal). Each region is graded on a scale from 0 (no staining) to 3 (severe staining) . The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage.
Change in Inferior corneal fluorescein staining score (iCFS) at week 12
Mean change from baseline in inferior corneal fluorescein staining score (iCFS), assessed using the modified National Eye Institute (NEI) scale. The cornea inferior region is graded on a scale from 0 (no staining) to 3 (severe staining) , with higher scores indicating more severe corneal epithelial damage.
Change in Sodium fluorescein tear film break-up time (FBUT) at week 12
Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12
Mean change from baseline in the Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at Week 12. The OSDI-6 is a patient-reported outcome instrument that assesses the frequency of dry eye symptoms and their impact on vision-related function over the past week. The total score ranges from 0 to 24, with higher scores indicating greater disability (more severe symptoms and impact on function).
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This trial is not recruiting at the moment. You can still explore other options:
