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)

N/ANot Yet RecruitingNCT07457021

Xiamen Ophthalmology Center Affiliated to Xiamen University2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Dry Eye Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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)" 2. Patients who meet the diagnostic criteria for dry eye as stipulated in the "Clinical Expert Consensus on Dry Eye in China (2020)" 3. Be at least 18 years old. 4. Voluntarily participate in this study and sign a written informed consent form. Exclusion Criteria: 1. 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); 2. Patients who used perfluorohexyloctane eye drops within 2 weeks before enrollment; 3. Patients who have participated in or are currently participating in clinical trials of other drugs or devices within one month; 4. 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).

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame: Week 12

Incidence of adverse events assessed by the investigator as related to the study drug

Time frame: Week 12

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.

Time frame: Week 12

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.

Time frame: Week 12

Fundus Examination Findings

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.

Time frame: Week 12

Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at 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.