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AzTrials

Dry Eye DiseaseNCT07457021

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)

An observational study of Dry Eye Disease, run by Xiamen Ophthalmology Center Affiliated to Xiamen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye Disease
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Mar 2026to 30 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shinan Wu, MD, PhD contact

+8613762300259

wshinana99@163.com

China1 site

  • Xiamen Eye Center Affiliated to Xiamen University

    Xiamen

    Shinan Wu, MD, PhD, +8613762300259, wshinana99@163.com

Other trials in China

About this study

Official title: 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.

Conditions
Dry Eye Disease
Medical subject headings
Dry Eye Syndromes

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 12

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

    Measured: Week 12

  3. 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.

    Measured: Week 12

  4. 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.

    Measured: Week 12

  5. 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.

    Measured: Week 12

  6. 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.

    Measured: Baseline and Week 12

Secondary outcomes (9)

  1. Change in Total Corneal Fluorescein Staining Score (tCFS) at 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.

    Measured: Baseline and Week 12

  2. Change in Inferior corneal fluorescein staining score (iCFS) at 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.

    Measured: Baseline and Week 12

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

    Measured: Baseline and Week 12

  4. Change in Ocular Surface Disease Index-6 (OSDI-6) questionnaire score at 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).

    Measured: Baseline and Week 12

  5. Change in Meibomian Gland Secretion Quality Score at 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),

    1. = mild (cloudy fluid),
    2. = moderate (cloudy, particulate fluid),
    3. = 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.

    Measured: Baseline and Week 12

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

    Measured: At baseline and week 8

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

    Measured: At baseline and week 4

  8. Change in Total Corneal Fluorescein Staining Score (tCFS) at 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.

    Measured: Baseline and Week 8

  9. Change in Total Corneal Fluorescein Staining Score (tCFS) at 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.

    Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457021
Sponsor's protocol ID
MA-OP-RWS-001
Status last verified
Mar 2026
First submitted
27 Feb 2026
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Disease, run by Xiamen Ophthalmology Center Affiliated to Xiamen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shinan Wu, MD, PhD (+8613762300259, wshinana99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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