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NCT07679685

PHASE4

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

Sponsor: Beijing Tongren Hospital

View on ClinicalTrials.gov

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.

Official title: A Prospective, Multicenter, Randomized Controlled Trial on the Efficacy and Safety of Perfluorohexyloctane Eye Drops Versus 0.1% Sodium Hyaluronate Eye Drops in the Treatment of Video Display Terminal-associated Dry Eye

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

159

Start Date

2026-06-30

Completion Date

2027-04-30

Last Updated

2026-07-01

Healthy Volunteers

Conditions

Dry Eye

Interventions

DRUG

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.

DRUG

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.

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.

Locations (9)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (9)