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)

NCT07457021 | Not Yet Recruiting

• 1 other identifier: MA-OP-RWS-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Week 12

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

  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.

  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.

  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.

  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.

  Baseline and Week 12

Secondary Outcomes (9)

• Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12

  Baseline and Week 12

• Change in Inferior corneal fluorescein staining score (iCFS) at week 12

  Baseline and Week 12

• Change in Sodium fluorescein tear film break-up time (FBUT) at week 12

  Baseline and Week 12

• Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at week 12

  Baseline and Week 12

• Change in Meibomian Gland Secretion Quality Score at Week 12

  Baseline and Week 12

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xiamen Ophthalmology Center Affiliated to Xiamen University: lead

Study Sites (1)

Xiamen Eye Center Affiliated to Xiamen University

Xiamen, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Shinan Wu, MD, PhD

CONTACT

+8613762300259; wshinana99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)