Perfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye
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.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Jin Yuan
- Telefonnummer: 010-58366699
- E-post: yuanjincornea@126.com
Studiesteder
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Beijing, Kina
- Chinese PLA General Hospital
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Ta kontakt med:
- Liqiang Wang
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Beijing, Kina
- Peking Union Medical College Hospital
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Ta kontakt med:
- Di Chen
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Beijing, Kina
- Beijing Aier-Intech Eye Hospital
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Guangzhou, Kina
- Guangdong Provincial People's Hospital
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Ta kontakt med:
- Honghua Yu
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Guangzhou, Kina
- Sun Yat-sen Memorial Hospital
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Ta kontakt med:
- Yuqing Lan
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Shanghai, Kina
- Eye & ENT Hospital of Fudan University
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Ta kontakt med:
- Lan Gong
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Xi'an, Kina
- Xi'an Fourth Hospital
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Ta kontakt med:
- Ying Li
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Zhongshan, Kina
- Zhongshan City People's Hospital
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Ta kontakt med:
- Naiyang Li
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
- Beijing Anzhen Hospital
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Ta kontakt med:
- Xinxiao Gao
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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.
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1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Andre navn:
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Eksperimentell: 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.
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1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fluorescein Tear Film Break-Up Time（FBUT）
Tidsramme: week 8
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Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8
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week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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standard patient evaluation of eye dryness（SPEED） Questionnaire
Tidsramme: Weeks 2, 4, and 8
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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.
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Weeks 2, 4, and 8
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Total Corneal Fluorescein Staining Score (tCFS)
Tidsramme: Weeks 2, 4, and 8
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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.
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Weeks 2, 4, and 8
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Partial Blink Rate (PBR)
Tidsramme: Weeks 2, 4, and 8
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Change from Baseline in Partial Blink Rate (PBR) at Weeks 2, 4, and 8
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Weeks 2, 4, and 8
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Non-Invasive Tear Film Break-Up Time (NIBUT)
Tidsramme: Weeks 2, 4, and 8
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Change from Baseline in Non-Invasive Tear Film Break-Up Time (NIBUT) at Weeks 2, 4, and 8
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Weeks 2, 4, and 8
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Meibomian Gland Secretion Quality Score
Tidsramme: Weeks 2, 4, and 8
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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.
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Weeks 2, 4, and 8
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jin Yuan, Beijing Tongren Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIT-VDT-PFHO-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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