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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 159
- 试验地点
- 9
- 主要终点
- Fluorescein Tear Film Break-Up Time（FBUT）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fluorescein Tear Film Break-Up Time（FBUT）
时间窗: week 8
Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8
次要结局
- standard patient evaluation of eye dryness（SPEED） Questionnaire(Weeks 2, 4, and 8)
- Total Corneal Fluorescein Staining Score (tCFS)(Weeks 2, 4, and 8)
- Partial Blink Rate (PBR)(Weeks 2, 4, and 8)
- Non-Invasive Tear Film Break-Up Time (NIBUT)(Weeks 2, 4, and 8)
- Meibomian Gland Secretion Quality Score(Weeks 2, 4, and 8)
研究者
Jinyuan,MD
President of Beijing Tongren Hospital
Beijing Tongren Hospital