Dry Eye Disease
Conditions
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.
Interventions
None listed
Sponsors
Xiamen Ophthalmology Center Affiliated to Xiamen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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)" 2. Patients who meet the diagnostic criteria for dry eye as stipulated in the "Clinical Expert Consensus on Dry Eye in China (2020)" 3. Be at least 18 years old. 4. Voluntarily participate in this study and sign a written informed consent form.
Exclusion criteria
1. 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); 2. Patients who used perfluorohexyloctane eye drops within 2 weeks before enrollment; 3. Patients who have participated in or are currently participating in clinical trials of other drugs or devices within one month; 4. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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] | 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. |
| Intraocular Pressure [IOP] | 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. |
| Fundus Examination Findings | 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. |
| Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score at week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 12 | 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. |
| Change in Inferior corneal fluorescein staining score (iCFS) at week 12 | 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. |
| 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 | 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). |
| Change in Meibomian Gland Secretion Quality Score at Week 12 | 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), 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. |
| 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 | 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. |
| Change in Total Corneal Fluorescein Staining Score (tCFS) at Week 4 | 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. |
Countries
China
Contacts
CONTACTShinan Wu, MD, PhD
Outcome results
None listed