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)

March 6, 2026 updated by: Xiamen Ophthalmology Center Affiliated to Xiamen University

Treating Dry Eye Disease Related to Meibomian Gland Dysfunction With Perfluorohexyloctane Eye Drops : A Prospective, Multicenter, Real-world Study

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 Overview

Status

Not yet recruiting

Conditions

Dry Eye Disease

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shinan Wu, MD, PhD
Phone Number: +8613762300259
Email: wshinana99@163.com

Study Locations

China
- - Xiamen, China
    - Xiamen Eye Center Affiliated to Xiamen University
    - Contact:
      
      Shinan Wu, MD, PhD
      
      Phone Number: +8613762300259
      
      Email: wshinana99@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Chinese patients with dry eye disease related to meibomian gland dysfunction who use perfluorohexyloctane eye drops

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (TEAEs) Time Frame: Week 12		Week 12
Incidence of adverse events assessed by the investigator as related to the study drug Time Frame: Week 12		Week 12
Uncorrected Visual Acuity [UCVA] Time Frame: 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.	Week 12
Intraocular Pressure [IOP] Time Frame: 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.	Week 12
Fundus Examination Findings Time Frame: 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.	Week 12
Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12 Time Frame: 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.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12 Time Frame: Baseline and 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.	Baseline and Week 12
Change in Inferior corneal fluorescein staining score (iCFS) at week 12 Time Frame: Baseline and 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.	Baseline and Week 12
Change in Sodium fluorescein tear film break-up time (FBUT) at week 12 Time Frame: Baseline and Week 12		Baseline and Week 12
Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12 Time Frame: Baseline and 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).	Baseline and Week 12
Change in Meibomian Gland Secretion Quality Score at Week 12 Time Frame: Baseline and Week 12	Mean change from baseline in meibomian gland secretion quality score at Week 12. Secretion quality is assessed by applying pressure to the 5 central glands of the lower eyelid of each eye. Each gland is graded on a scale from 0 to 3, where: 0 = normal (clear, transparent fluid), = mild (cloudy fluid), = moderate (cloudy, particulate fluid), = severe (thick, toothpaste-like meibum). The scores from the 5 glands are summed, resulting in a total score range from 0 to 15 per eye. Higher scores indicate more severe meibomian gland dysfunction.	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		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		At baseline and week 4
Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 8 Time Frame: Baseline and Week 8	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.	Baseline and Week 8
Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 4 Time Frame: Baseline and Week 4	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.	Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Ophthalmology Center Affiliated to Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)