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Dry EyePhase 4NCT07679685

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

A Phase 4 study testing 0.1% Sodium Hyaluronate Eye Drops and Perfluorohexyloctane Eye Drops (PFHO) in people with Dry Eye, run by Beijing Tongren Hospital at 9 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dry Eye
What is being tested?
0.1% Sodium Hyaluronate Eye Drops and Perfluorohexyloctane Eye Drops (PFHO)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
9 sitesChina
Study dates
30 Jun 2026to 30 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Yuan contact

010-58366699

yuanjincornea@126.com

9 sites in 1 country

China9 sites

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

    Xinxiao Gao

  • Beijing Aier-Intech Eye Hospital

    Beijing

  • Chinese PLA General Hospital

    Beijing

    Liqiang Wang

  • Peking Union Medical College Hospital

    Beijing

    Di Chen

  • Guangdong Provincial People's Hospital

    Guangzhou

    Honghua Yu

  • Sun Yat-sen Memorial Hospital

    Guangzhou

    Yuqing Lan

  • Eye & ENT Hospital of Fudan University

    Shanghai

    Lan Gong

  • Xi'an Fourth Hospital

    Xi'an

    Ying Li

  • Zhongshan City People's Hospital

    Zhongshan

    Naiyang Li

Other trials in China

About this study

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

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.

Read more

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
Being tested
0.1% Sodium Hyaluronate Eye Drops, Perfluorohexyloctane Eye Drops (PFHO)
Keywords
Dry eye, video display terminal
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.1% Sodium Hyaluronate Eye DropsDrug

    Also called Hialid®，Santen Pharmaceutical(China) Co., Ltd

    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)Drug

    Also called Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.

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

Study groups in NCT07679685
Study groupRoleWhat they receive
0.1% Sodium Hyaluronate Eye DropsActive comparator1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Receives: Drug: 0.1% Sodium Hyaluronate Eye Drops
Perfluorohexyloctane Eye Drops (PFHO)Experimental1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Receives: Drug: Perfluorohexyloctane Eye Drops (PFHO)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: week 8

Secondary outcomes (5)

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

    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.

    Measured: Weeks 2, 4, and 8

  2. Total Corneal Fluorescein Staining Score (tCFS)

    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.

    Measured: Weeks 2, 4, and 8

  3. Partial Blink Rate (PBR)

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

    Measured: Weeks 2, 4, and 8

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

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

    Measured: Weeks 2, 4, and 8

  5. Meibomian Gland Secretion Quality Score

    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.

    Measured: Weeks 2, 4, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
159 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07679685
Sponsor's protocol ID
IIT-VDT-PFHO-2026
Status last verified
Jun 2026
First submitted
24 Jun 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37866176

  • 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.

    PubMed 23891330

  • 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.

    PubMed 29881936

  • 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.

    PubMed 25144638

  • 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.

    PubMed 36948372

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.1% Sodium Hyaluronate Eye Drops and Perfluorohexyloctane Eye Drops (PFHO) in people with Dry Eye, run by Beijing Tongren Hospital at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Yuan (010-58366699, yuanjincornea@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluorescein Tear Film Break-Up Time（FBUT） (time frame: week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07679685, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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