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NCT Number: NCT07457021

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)

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Week 12

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

    Time frame: Week 12

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

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

    Time frame: Baseline and Week 12

  4. 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).

  5. 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.

  6. Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 8

    Time frame: At baseline and week 8

  7. Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 4

    Time frame: At baseline and week 4

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shinan Wu, MD, PhD

CONTACT

[email protected]

+8613762300259

Sponsors and collaborators

Lead sponsor

Xiamen Ophthalmology Center Affiliated to Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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