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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treating Dry Eye Disease Related to Meibomian Gland Dysfunction With Perfluorohexyloctane Eye Drops : A Prospective, Multicenter, Real-world Study
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.
Primary outcome measures
- 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] [Time frame: Week 12]
- Intraocular Pressure [IOP] [Time frame: Week 12]
- Fundus Examination Findings [Time frame: Week 12]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12 [Time frame: Baseline and Week 12]
Secondary outcome measures (9)
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12 [Time frame: Baseline and Week 12]
- Change in Inferior corneal fluorescein staining score (iCFS) at week 12 [Time frame: Baseline and Week 12]
- Change in Sodium fluorescein tear film break-up time (FBUT) at week 12 [Time frame: Baseline and Week 12]
- Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12 [Time frame: Baseline and Week 12]
- Change in Meibomian Gland Secretion Quality Score at Week 12 [Time frame: Baseline and Week 12]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 8 [Time frame: At baseline and week 8]
- Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 4 [Time frame: At baseline and week 4]
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 8 [Time frame: Baseline and Week 8]
- Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 4 [Time frame: Baseline and Week 4]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xiamen Eye Center Affiliated to Xiamen University — Xiamen
Identifiers
NCT: NCT07457021 · MA-OP-RWS-001