ClinicalTrials.gg
Not yet recruitingNCT07679685Updated Jul 1, 2026

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

A Phase 4 interventional study of 0.1% Sodium Hyaluronate Eye Drops and Perfluorohexyloctane Eye Drops (PFHO) in Dry Eye, sponsored by Beijing Tongren Hospital. Not yet recruiting at 9 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Beijing Tongren Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing perfluorohexyloctane in Dry Eye Syndromes — 1 open to participants now, 2 under way, none of them phase 3. perfluorohexyloctane · Dry Eye Syndromes.

Planned enrollment
8th of 13
159 · median 216
Started
2026
with 1 other
Phase 4
7 of 13
1 open now
Registered
13th of 13
by date
Lead sponsor
1 of 13
Beijing Tongren Hospital

Among the 13 studies testing perfluorohexyloctane in Dry Eye Syndromes, this one is the 8th largest by planned enrollment, is one of 2 that started in 2026, is one of 7 in phase 4, and was the 13th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Phase 4this study7 · 1 open
Phase 34 · 0 open
Phase 22 · 0 open

By the year they started

First in 2018; this study’s year is marked. 2 started in 2026.

Tested beside perfluorohexyloctane

Size and results

Median enrollment 216 across the 13 interventional studies. Of the 10 that completed or were terminated, 6 (60%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies testing perfluorohexyloctane in Dry Eye Syndromes, or all of them as a file.
02

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.

03

Conditions studied

  • Dry Eye

Browse trials for

Keywords

  • Dry eye
  • video display terminal
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  1. Allergy or 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, , 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (estimated)

Study arms

  • Active comparator
    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: 0.1% Sodium Hyaluronate Eye Drops

  • Experimental
    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.

    Drug: Perfluorohexyloctane Eye Drops (PFHO)

Interventions

  • 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

  • 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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: week 8

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: Weeks 2, 4, and 8

  3. Partial Blink Rate (PBR)

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

    Time frame: 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

    Time frame: 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.

    Time frame: Weeks 2, 4, and 8

07

Study locations

9 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Feb 2027, 7 months later.

Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 7 months is below that.

Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2026
First posted
Jul 1, 2026
StartEst.
Jun 30, 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
Apr 30, 2027
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07679685
Responsible party
Jinyuan,MD (President of Beijing Tongren Hospital, Beijing Tongren Hospital) — Principal investigator
First posted
Jul 1, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

Jin Yuan
Contact
yuanjincornea@126.com
010-58366699
Jin Yuan
principal investigator · Beijing Tongren Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Perfluorohexyloctane

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