Dry Eye
Conditions
Keywords
Dry eye, video display terminal
Brief summary
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops in patients with video display terminal (VDT)-associated dry eye. Participants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use video display terminal for more than 6 hours/day and at least 5 days/week for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop/eye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks. The primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, standard patient evaluation of eye dryness（SPEED） questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops (Hialid®) in patients with video display terminal (VDT)-associated dry eye. Participants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use electronic screens for more than 6 hours/day and at least 5 days/week for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop/eye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks. The primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, SPEED questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and meibography score at Weeks 2, 4, and 8.
Interventions
DRUG0.1% Sodium Hyaluronate Eye Drops
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
DRUGPerfluorohexyloctane Eye Drops (PFHO)
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years (inclusive), male or female; 2. Subject reports dry eye symptoms for at least 6 months; 3. Diagnosis of mild to moderate dry eye according to the Chinese Dry Eye Expert Consensus (2020) criteria: * Mild dry eye: fluorescein tear film break-up time (FBUT) ≥2 seconds, no significant ocular surface damage signs, corneal fluorescein staining score \<5; * Moderate dry eye: FBUT ≥2 seconds AND corneal fluorescein staining dots \<30 or not exceeding 2 quadrants; 4. Normal tear secretion: Schirmer I test ≥10 mm/5 min; 5. Daily electronic screen usage \>6 hours; 6. Electronic screen use for at least 5 days/week, for more than 1 year; 7. Understands and provides written informed consent.
Exclusion criteria
1. Allergy or hypersensitivity to any component of the study drugs; 2. Requires the use of artificial tears (other than study drug), secretagogues, ocular surface repair agents, anti-inflammatory/antibiotic eye drops, or other dry eye-related drugs (e.g., muscarinic receptor blockers for visual fatigue) during the study period; 3. Presence of any of the following ocular or systemic conditions: * Active ocular infection, ocular inflammation, or active ocular allergy; * Conjunctivochalasis, nasolacrimal duct obstruction; * Glaucoma or elevated intraocular pressure; * Retinal disease or ocular tumor; * Requirement to wear contact lenses during the study; * Obstructive sleep apnea syndrome or sleep disorders; * Planned or ongoing physical therapy (intense pulsed light, meibomian gland massage, warm compress, thermopulsation) within 2 weeks before enrollment through the end of study; 4. Ocular surgery within 3 months prior to enrollment, incomplete recovery from previous ocular surgery, or planned ophthalmic surgery during the study period; 5. Current smoker; 6. Pregnant or breastfeeding women, or women planning to become pregnant during the study period; 7. Uncontrolled systemic disease, or use of systemic medications (e.g., beta-blockers, benzodiazepines, corticosteroids, antihistamines, or other medications that may interfere with tear production); 8. History of anxiety or depression; 9. Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Tear Film Break-Up Time（FBUT） | week 8 | Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| standard patient evaluation of eye dryness（SPEED） Questionnaire | Weeks 2, 4, and 8 | 1.Change from Baseline in SPEED Questionnaire Score at Weeks 2, 4, and 8 2.Scores range from 0 to 28, with higher scores indicating more severe symptoms. |
| Total Corneal Fluorescein Staining Score (tCFS) | Weeks 2, 4, and 8 | 1.Change from Baseline in Total Corneal Fluorescein Staining Score (tCFS) at Weeks 2, 4, and 8；2.The cornea was divided into five regions: superior, central, inferior, nasal, and temporal. Each region was scored from 0 to 3, yielding a total score ranging from 0 to 15, with higher scores indicating more severe signs. |
| Partial Blink Rate (PBR) | Weeks 2, 4, and 8 | Change from Baseline in Partial Blink Rate (PBR) at Weeks 2, 4, and 8 |
| Non-Invasive Tear Film Break-Up Time (NIBUT) | Weeks 2, 4, and 8 | Change from Baseline in Non-Invasive Tear Film Break-Up Time (NIBUT) at Weeks 2, 4, and 8 |
| Meibomian Gland Secretion Quality Score | Weeks 2, 4, and 8 | 1.Change from Baseline in Meibomian Gland Secretion Quality Score at Weeks 2, 4, and 8；2.The central lower eyelid margin was gently pressed with a cotton swab to evaluate five meibomian glands. The secretion quality of each gland was graded on a scale of 0 to 3. The total score ranged from 0 to 15, with higher scores indicating poorer meibum quality. |
Countries
China
Contacts
CONTACTJin Yuan
PRINCIPAL_INVESTIGATORJin Yuan
Beijing Tongren Hospital
Outcome results
None listed