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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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients with dry eye disease related to meibomian gland dysfunction who use perfluorohexyloctane eye drops
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinan Wu, MD, PhD | Contact | +8613762300259 | wshinana99@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Eye Center Affiliated to Xiamen University | Xiamen | China |
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| Baseline and Week 12 |
| 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. | 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 | 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 | 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),
| Baseline and Week 12 |
| Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 8 | At baseline and week 8 |
| Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 4 | At baseline and week 4 |
| 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. | Baseline and Week 8 |
| 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. | Baseline and Week 4 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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