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.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Jin Yuan
- 电话号码：010-58366699
- 邮箱：yuanjincornea@126.com
学习地点
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Beijing、中国
- Chinese PLA General Hospital
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接触：
- Liqiang Wang
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Beijing、中国
- Peking Union Medical College Hospital
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接触：
- Di Chen
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Beijing、中国
- Beijing Aier-Intech Eye Hospital
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Guangzhou、中国
- Guangdong Provincial People's Hospital
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接触：
- Honghua Yu
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Guangzhou、中国
- Sun Yat-sen Memorial Hospital
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接触：
- Yuqing Lan
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Shanghai、中国
- Eye & ENT Hospital of Fudan University
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接触：
- Lan Gong
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Xi'an、中国
- Xi'an Fourth Hospital
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接触：
- Ying Li
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Zhongshan、中国
- Zhongshan City People's Hospital
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接触：
- Naiyang Li
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- Beijing Anzhen Hospital
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接触：
- Xinxiao Gao
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
其他名称：
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实验性的：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fluorescein Tear Film Break-Up Time（FBUT）
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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standard patient evaluation of eye dryness（SPEED） Questionnaire
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Jin Yuan、Beijing Tongren Hospital
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IIT-VDT-PFHO-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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