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NCT Number: NCT07679685

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation.

Treatment and study plan

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.

Other names: Hialid®,Santen Pharmaceutical(China) Co., Ltd

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.

Other names: Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.

Primary outcomes

  1. Fluorescein Tear Film Break-Up Time(FBUT)

    Time frame: week 8

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

Secondary outcomes

  1. standard patient evaluation of eye dryness(SPEED) Questionnaire

    Time frame: 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.

  2. Total Corneal Fluorescein Staining Score (tCFS)

    Time frame: 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.

  3. Partial Blink Rate (PBR)

    Time frame: Weeks 2, 4, and 8

    Change from Baseline in Partial Blink Rate (PBR) at Weeks 2, 4, and 8

  4. Non-Invasive Tear Film Break-Up Time (NIBUT)

    Time frame: Weeks 2, 4, and 8

    Change from Baseline in Non-Invasive Tear Film Break-Up Time (NIBUT) at Weeks 2, 4, and 8

  5. Meibomian Gland Secretion Quality Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Yuan

CONTACT

[email protected]

010-58366699

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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