The Effect of Autologous Serum Tears Diluted to 50% With 0.2% Sodium Hyaluronate-Containing Preservative-Free Artificial Tears Versus Autologous Serum Tears Diluted to 50% With Balanced Salt Solution in Patients With Moderate-to-Severe Dry Eye Disease: A Prospective, Double-Blind, Randomized, Controlled, Contralateral-Eye Study
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
概览
简要总结
This study aims to find out whether adding sodium hyaluronate, a moisturizing ingredient commonly found in artificial tears, makes autologous serum eye drops more effective for treating moderate-to-severe dry eye disease. Each participant will use one version of the drops in one eye and the standard version in the other eye. The goal is to see if the new combination provides better relief, comfort, and eye surface healing compared to the traditional formulation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Formal diagnosis of one of the following conditions associated with aqueous-deficient dry eye disease: Sjögren's syndrome (primary or secondary), Mucous membrane pemphigoid, Graft-versus-host disease, Stevens-Johnson syndrome, Post-radiation lacrimal gland aqueous deficiency, or Neurotrophic keratitis
- •Moderate-to-severe Dry Eye Disease (DED) symptoms for at least 6 months prior to study enrollment.
- •OSDI score ≥ 25 and/or and OSDI-6 score \> 6 at the screening visit
- •Presence of at least two of the following clinical signs in the same eye, at the screening visit: Anesthetized Schirmer's test score 7 ≤ mm at 5 minutes, Tear Break up Time (TBUT) ≤ 7 seconds, Corneal fluorescein staining score ≥ 4 (maximum 15) as assessed by the National Eye Institute (NEI) grading scale 25, or Conjunctival lissamine green staining ≥ 3 (maximum 18) as assessed by the NEI grading scale
- •Desire to use autologous serum tears at least twice daily in the 2 weeks prior to screening visit.
排除标准
- •Age \<18 years old.
- •Cognitive impairment or psychiatric condition that precludes informed consent or the ability to comply with study procedures.
- •Any clinical condition identified at screening that, in the opinion of the treating physician, is clinically significant and would contraindicate safe participation in the study.
- •Any condition or treatment known to affect the signs and symptoms of DED, including pregnancy, regular use of contact lenses, recent diagnosis of ocular allergy, infection, or inflammation, or recent ocular surgery within 6 months.
- •Patients with stable ocular surface disease or neurotrophic keratitis secondary to prior ocular surgery, chronic glaucoma therapy, or eyelid abnormalities may be included.
研究组 & 干预措施
Autologous Serum Tears + Sodium Hyaluronate (Eye A)
All participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months.
干预措施: Autologous Serum Tears (50% Autologous Serum Tears + 0.2% Sodium Hyaluronate) (Biological)
Autologous Serum Tears + Sodium Hyaluronate (Eye A)
All participants will continue their standard-of-care treatment throughout the study. One eye of each participant will receive autologous serum tears diluted to 50% with 0.2% sodium hyaluronate preservative-free artificial tears 4 times daily for 3 months.
干预措施: Standard of Care (SOC) Treatment (Other)
Autologous Serum Tears + Balanced Saline Solution (Eye B)
All participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months.
干预措施: Biological - Autologous Serum Tears (50% Autologous Serum Tears + Balanced Saline Solution (BSS) (Biological)
Autologous Serum Tears + Balanced Saline Solution (Eye B)
All participants will continue their standard-of-care treatment throughout the study. The fellow eye of each participant will receive autologous serum tears diluted to 50% with Balanced Saline Solution 4 times daily for 3 months.
干预措施: Standard of Care (SOC) Treatment (Other)
结局指标
主要结局
OSDI (Ocular Surface Disease Index) Symptom Score (0-100)
时间窗: Baseline, Approximately 12 weeks
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI) questionnaire, scored from 0 to 100, with higher scores indicating greater symptom severity.
OSDI (Ocular Surface Disease Index)-6 Symptom Score (0-12)
时间窗: Baseline, Approximately 12 weeks
Change in dry eye symptom severity measured using the Ocular Surface Disease Index (OSDI-6)questionnaire, scored from 0 to 12, with higher scores indicating greater symptom severity.
Tear production (mm of wetting in 5 Minutes)
时间窗: Baseline, week 4,week 8,week 12
Tear production measured using anesthetized Schirmer's test, reported as millimeters of strip wetting over 5 minutes.
Tear Break Up Time (Seconds)
时间窗: Baseline, week 4,week 8,week 12
Mean fluorescein Tear Break Up Time Using slit-lamp and fluorescein dye to review cornea and determine how long it takes for dry spots to occur. Calculated as the average of three measurements and reported in seconds
Corneal Fluorescein Staining (National Eye Institute Score (NEI) 0-15)
时间窗: Baseline, week 4,week 8,week 12
Corneal staining severity graded using the NEI scale (0-15), with higher scores indicating more extensive staining
Conjunctival Lissamine Green Staining (NEI Score 0-18)
时间窗: Baseline, week 4,week 8,week 12
Conjunctival staining severity graded using the NEI scale (0-18), with higher scores indicating more extensive staining.
In Vivo Confocal Microscopy Parameters (Quantitative Cellular and Nerve Metrics)
时间窗: Baseline, week 4,week 8,week 12
Quantitative assessment of corneal cellular structures and sub-basal nerve plexus morphology using in vivo confocal microscopy. Measured in mm/mm².
Keratograph 5M Measurement: Non-Invasive Keratographic Break-Up Time (Seconds)
时间窗: Baseline, week 4, week 8, week 12
Non-invasive keratographic break-up time (NIKBUT) will be measured using the Keratograph 5M ocular surface imaging system. Participants will blink normally and then keep their eyes open while the device records the time in seconds until tear film break-up occurs. Higher values indicate greater tear film stability.
Keratograph 5M Tear Meniscus Height (mm)
时间窗: Baseline, week 4, week 8, week 12
Tear meniscus height (TMH) will be measured using the Keratograph 5M non-invasive ocular surface imaging system. The Keratograph 5M software will automatically detect and calculate tear meniscus height in millimeters.
Keratograph 5M Measurement: Meibography Grade
时间窗: Baseline, week 4, week 8, week 12
Meibography will be performed using the Keratograph 5M non-contact infrared imaging system to assess meibomian gland structure in the upper and lower eyelids. Meibography grading of meibomian gland dropout using a unitless 0-6 meiboscore scale.
Visual Acuity (logMAR Units)
时间窗: Baseline, week 4, week 8, week 12
Uncorrected and best-corrected Visual Acuity measured using a standardized logMAR chart and reported in logMAR units
次要结局
未报告次要终点
研究者
Sotiria Palioura
Professor of Clinical Ophthalmology
University of Miami