Comparative Efficacy of 3% Diquafosol Sodium Eye Drops in Dry Eye Patients Across Age Groups: a Propensity Score-Matched Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Dry Eye Questionnaire Score (DEQS)
研究概览
简要总结
This study aimed to evaluate the efficacy of 3% diquafosol sodium eye drops in treating dry eye disease (DED) across different age groups using a propensity score-matched longitudinal design.
详细描述
1 ）Participants and Study Design
This prospective clinical trial was conducted following ethical principles and received approval from the Ethics Committee of Tianjin Eye Hospital of China (Approval No.: TJYYLCSYSCLL-2021-25). The study adhered to the tenets of the Declaration of Helsinki, and all patients provided written informed consent after receiving a detailed explanation of the study protocols and the potential consequences associated with participation.
Inclusion Criteria: Patients with Dry Eye Disease (DED) were eligible if they met one of the following criteria:
- They reported symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with a Chinese dry eye questionnaire score (DEQS) ≥7. Additionally, they had either a fluorescein tear breakup time (FBUT) ≤5 s, a non-invasive tear breakup time (NIBUT) <10 s, or a Schirmer I test (without anesthesia) ≤5 mm/5 min.
- They had dry eye-related symptoms with a Chinese DEQS ≥7. Additionally, they had either FBUT >5 s and ≤10 s, NIBUT between 10 and 12 s, or a Schirmer I test (without anesthesia) >5 mm/5 min and ≤10 mm/5 min. Furthermore, patients were required to have positive fluorescein staining (≥5 spots) for diagnosis.
Exclusion Criteria: Excluded were patients with allergies to any component of the drugs or diagnostic agents used; those who had used 3% diquafosol sodium eye drops within 2 weeks before enrollment; any systemic conditions affecting ocular medication; and corneal disorders preventing diagnostic tests, such as keratitis and corneal dystrophy. The exclusion criteria also included concurrent use of ocular or systemic NSAIDs, steroids, or immunosuppressants; recent use of eye drops; recent physical therapy or ocular surgery; recent contact lens wear; punctual plug treatment; independent ocular diseases requiring additional treatment; and pregnant or breastfeeding women or those planning to become pregnant. All female patients of childbearing age tested negative in a urine pregnancy test before enrollment. If both eyes met the inclusion criteria, the eye with the shorter FBUT was selected. If both eyes had the same FBUT, the right eye was selected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria were based on the Chinese diagnostic criteria for DED
- •Patients with DED were eligible if they met one of the following criteria:
- •They reported symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with a Chinese dry eye questionnaire score (DEQS) ≥
- •Additionally, they had either a fluorescein tear breakup time (FBUT) ≤5 s, a non-invasive tear breakup time (NIBUT) <10 s, or a Schirmer I test (without anesthesia) ≤5 mm/5 min.
- •They had dry eye-related symptoms with a Chinese DEQS ≥
- •Additionally, they had either FBUT >5 s and ≤10 s, NIBUT between 10 and 12 s, or a Schirmer I test (without anesthesia) >5 mm/5 min and ≤10 mm/5 min. Furthermore, patients were required to have positive fluorescein staining (≥5 spots) for diagnosis.
排除标准
- •Excluded were patients with allergies to any component of the drugs or diagnostic agents used; those who had used 3% diquafosol sodium eye drops within 2 weeks before enrollment; any systemic conditions affecting ocular medication; and corneal disorders preventing diagnostic tests, such as keratitis and corneal dystrophy. The exclusion criteria also included concurrent use of ocular or systemic NSAIDs, steroids, or immunosuppressants; recent use of eye drops; recent physical therapy or ocular surgery; recent contact lens wear; punctal plug treatment; independent ocular diseases requiring additional treatment; and pregnant or breastfeeding women or those planning to become pregnant. All female patients of childbearing age tested negative in a urine pregnancy test prior to enrollment. If both eyes met the inclusion criteria, the eye with the shorter FBUT was selected. If both eyes had the same FBUT, the right eye was selected.
研究组 & 干预措施
Older group
Patients were divided into two groups based on age: the younger group (<40 years) and the older group (≥40 years). PSM (1:1) was used to ensure no significant differences in baseline characteristics between the two groups
干预措施: 3% Diquafosol Sodium Eye Drops (Drug)
Younger group
Patients were divided into two groups based on age: the younger group (<40 years) and the older group (≥40 years). PSM (1:1) was used to ensure no significant differences in baseline characteristics between the two groups
干预措施: 3% Diquafosol Sodium Eye Drops (Drug)
结局指标
主要结局
Dry Eye Questionnaire Score (DEQS)
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
DEQS was administered first to assess the subjective symptoms of dry eye. Patients were asked to complete a questionnaire that included multiple items evaluating discomfort and the impact of dry eyes on daily life. The scores were calculated using a standardized DEQS scoring system.
Visual Acuity (VA):
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
VA was measured using a 5 m standard Snellen chart and recorded in decimal notation. VA was then converted to the Logarithm of the Minimum Angle of Resolution (LogMAR) format for statistical analysis.
Lipid Layer Thickness:
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
The lipid layer thickness was evaluated using a LipiView interferometer based on the principle of white-light interference.
Tear Meniscus Height (TMH):
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
TMH was measured using an ocular surface analyzer. This device captured images of the tear meniscus at the lower eyelid margin to assess tear volume.
Meibomian Gland Dropout Area (MGDA):
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
MGDA was examined using an ocular surface analyzer (Oculus, Wetzlar, Germany). Infrared imaging was employed to visualize the meibomian glands in the eyelids, and the extent of gland dropout was quantified using the ImageJ software version 1.54j (National Institute of Health, Bethesda, MD, USA).
Schirmer I Test:
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
Schirmer I test was performed without anesthesia. Standardized Schirmer strips were placed at the junction of the middle and lateral thirds of the lower eyelid margins for 5 min. Wetting length on the strip was measured in millimeters to assess basal and reflex tear production. This test was performed at least 30 min after the FBUT test to prevent interference.
Fluorescein Tear Breakup Time (FBUT):
时间窗: Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.
FBUT was measured by instilling a fluorescein dye into the conjunctival sac and instructing the patient to blink several times to spread the dye uniformly. The time from the last blink to the first appearance of a dry spot on the corneal surface was recorded using a slit-lamp biomicroscope (Nidek. Gamagori, Japan) with a cobalt blue light. The test was performed thrice for each eye, and the average time was calculated.
次要结局
- Intraocular Pressure (IOP):(Follow-up examinations were conducted at baseline, 1 month, and 3 months after treatment initiation.)