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

NCT07679685 | Not Yet Recruiting Phase 4

• 1 other identifier: IIT-VDT-PFHO-2026
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 9

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.

Conditions

Dry Eye

Keywords

Dry eye; video display terminal

Outcome Measures

Primary Outcomes (1)

• Fluorescein Tear Film Break-Up Time（FBUT）

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

  week 8

Secondary Outcomes (5)

• standard patient evaluation of eye dryness（SPEED） Questionnaire

  Weeks 2, 4, and 8

• Total Corneal Fluorescein Staining Score (tCFS)

  Weeks 2, 4, and 8

• Partial Blink Rate (PBR)

  Weeks 2, 4, and 8

• Non-Invasive Tear Film Break-Up Time (NIBUT)

  Weeks 2, 4, and 8

• Meibomian Gland Secretion Quality Score

  Weeks 2, 4, and 8

Study Arms (2)

0.1% Sodium Hyaluronate Eye Drops

ACTIVE COMPARATOR

1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.

Drug: 0.1% Sodium Hyaluronate Eye Drops

Perfluorohexyloctane Eye Drops (PFHO)

EXPERIMENTAL

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)

Interventions

0.1% Sodium Hyaluronate Eye Drops DRUG

1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.

Also known as: Hialid®，Santen Pharmaceutical(China) Co., Ltd

0.1% Sodium Hyaluronate Eye Drops

Perfluorohexyloctane Eye Drops (PFHO) DRUG

1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.

Also known as: Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.

Perfluorohexyloctane Eye Drops (PFHO)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years (inclusive), male or female;
• Subject reports dry eye symptoms for at least 6 months;
• 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;
• Normal tear secretion: Schirmer I test ≥10 mm/5 min;
• Daily electronic screen usage \>6 hours;
• Electronic screen use for at least 5 days/week, for more than 1 year;
• Understands and provides written informed consent.

You may not qualify if:

• Allergy or hypersensitivity to any component of the study drugs;
• 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;
• 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;
• Ocular surgery within 3 months prior to enrollment, incomplete recovery from previous ocular surgery, or planned ophthalmic surgery during the study period;
• Current smoker;
• Pregnant or breastfeeding women, or women planning to become pregnant during the study period;
• Uncontrolled systemic disease, or use of systemic medications (e.g., beta-blockers, benzodiazepines, corticosteroids, antihistamines, or other medications that may interfere with tear production);
• History of anxiety or depression;

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (9)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Location

Beijing Aier-Intech Eye Hospital

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, China

Location

Xi'an Fourth Hospital

Xi'an, China

Location

Zhongshan City People's Hospital

Zhongshan, China

Location

Related Publications (5)

• Ccami-Bernal F, Soriano-Moreno DR, Romero-Robles MA, Barriga-Chambi F, Tuco KG, Castro-Diaz SD, Nunez-Lupaca JN, Pacheco-Mendoza J, Galvez-Olortegui T, Benites-Zapata VA. Prevalence of computer vision syndrome: A systematic review and meta-analysis. J Optom. 2024 Jan-Mar;17(1):100482. doi: 10.1016/j.optom.2023.100482. Epub 2023 Oct 30.

  PMID: 37866176 BACKGROUND

• Uchino M, Yokoi N, Uchino Y, Dogru M, Kawashima M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Schaumberg DA, Tsubota K. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013 Oct;156(4):759-66. doi: 10.1016/j.ajo.2013.05.040. Epub 2013 Jul 24.

  PMID: 23891330 BACKGROUND

• Rossi GCM, Scudeller L, Bettio F, Pasinetti GM, Bianchi PE. Prevalence of dry eye in video display terminal users: a cross-sectional Caucasian study in Italy. Int Ophthalmol. 2019 Jun;39(6):1315-1322. doi: 10.1007/s10792-018-0947-6. Epub 2018 Jun 7.

  PMID: 29881936 BACKGROUND

• Wu H, Wang Y, Dong N, Yang F, Lin Z, Shang X, Li C. Meibomian gland dysfunction determines the severity of the dry eye conditions in visual display terminal workers. PLoS One. 2014 Aug 21;9(8):e105575. doi: 10.1371/journal.pone.0105575. eCollection 2014.

  PMID: 25144638 BACKGROUND

• Sheppard JD, Kurata F, Epitropoulos AT, Krosser S, Vittitow JL; MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/j.ajo.2023.03.008. Epub 2023 Mar 21.

  PMID: 36948372 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jin Yuan

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Yuan

CONTACT

010-58366699; yuanjincornea@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tongren Hospital

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)