A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment o… (NCT07457021) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
China2,000 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses perfluorohexyloctane eye drops specifically for dry eye caused by meibomian gland dysfunction — do you think my dry eye is actually linked to MGD, and would that make this worth discussing as an option?
2The trial isn't recruiting yet, so there's no safety or effectiveness data available for this specific product — given that, would it make more sense to try an established dry eye treatment first while we wait to see if this study opens?
3The study is measuring things like intraocular pressure, visual acuity, and fundus exam findings — what does it tell you that they're tracking these particular safety markers, and does that suggest any risks I should be aware of?
4One of the main things this trial is measuring is change in my self-reported dry eye symptom score at 12 weeks using the SPEED questionnaire — how meaningful would a change in that score actually be for how I feel day to day, and is 12 weeks long enough to know if something is really working?
5Since this study has no assigned phase, what does that mean about how much is already known about this eye drop's safety in humans, and how would you weigh that uncertainty against other treatment options available to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Week 12
2
Incidence of adverse events assessed by the investigator as related to the study drug
Timeframe: Week 12
3
Uncorrected Visual Acuity [UCVA]
Timeframe: Week 12
4
Intraocular Pressure [IOP]
Timeframe: Week 12
5
Fundus Examination Findings
Timeframe: Week 12
6
Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12
Timeframe: Baseline and Week 12
Trial details
NCT IDNCT07457021
SponsorXiamen Ophthalmology Center Affiliated to Xiamen University
. 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).