Perfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye

NCT07679685 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tongren Hospital

Phase

Phase 4

Started

2026-06-30

Last updated

2026-07-01

Condition(s) studied

Dry Eye

Investigational drug(s) / intervention(s)

0.1% Sodium Hyaluronate Eye Drops →Perfluorohexyloctane Eye Drops (PFHO)

0.1% 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.

Perfluorohexyloctane 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Fluorescein Tear Film Break-Up Time（FBUT） — week 8
Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8

Trial sites (9)

Facility	City	Region
Beijing Anzhen Hospital	Beijing	Beijing Municipality
Beijing Aier-Intech Eye Hospital	Beijing	China
Chinese PLA General Hospital	Beijing	China
Peking Union Medical College Hospital	Beijing	China
Guangdong Provincial People's Hospital	Guangzhou	China
Sun Yat-sen Memorial Hospital	Guangzhou	China
Eye & ENT Hospital of Fudan University	Shanghai	China
Xi'an Fourth Hospital	Xi'an	China
Zhongshan City People's Hospital	Zhongshan	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07679685 on ClinicalTrials.gov ↗ ← All trials in China