Short-term Supplemental Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease - A Randomized, Parallel-group, Double-blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Tear meniscus height
研究概览
简要总结
This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.
详细描述
This trial is a randomized, parallel-group, double-blind, controlled clinical trial to compare intervention treatment (Per-Young Eye Drops: preservative-free 0.15% HA) against control treatment (AIM Artificial Tears: salt solution without 0.15% HA). All participants will be received Per-Young Eye Drops (4 to 8 times per day) or AIM Artificial Tears (4 to 8 times per day) with 12 weeks. Two drugs are identical in appearance and order of administration will be double-blind randomized.
Primary endpoint:
To compare the central tear meniscus height (TMHc) of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged greater than or equal to 20 years (>= 20 years).
- •The symptom criterium of ocular surface disease index (OSDI) score >
- •One of the two following examination criteria:
- •Central tear meniscus height (TMHc) < 0.20 mm,
- •Noninvasive tear-break time (NITBUT) < 6 s, for at least one eye.
- •Informed consent form (ICF) signed by the participant or a legal guardian.
排除标准
- •Male or female subjects aged less than 20 years (<20 years).
- •The symptom criterium of ocular surface disease index (OSDI) score <
- •Central tear meniscus height (TMHc) > 0.20 mm and Noninvasive tear-break time (NITBUT) > 6 s for each eye.
- •Acute inflammatory eye diseases.
- •Receive ocular or eyelid surgeries before 6 months (except cataract surgery).
- •Allergy to HA
- •Pregnancy
- •Conditions judged by the investigator as unsuitable for this trial.
研究组 & 干预措施
salt solution without 0.15% HA
干预措施: salt solution without 0.15% HA (Drug)
preservative-free 0.15% HA
干预措施: preservative-free 0.15% HA (Drug)
结局指标
主要结局
Tear meniscus height
时间窗: 4 weeks
To compare the TMHc after blink of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.
次要结局
- Redness score(8 weeks and 12 weeks)
- Non-invasive tear break-up time (NITBUT)(8 weeks, 12 weeks)
- Tear fern test(8 weeks, 12 weeks)
- Tear film dynamics(8 weeks, 12 weeks)
- Tear meniscus height(8 weeks and 12 weeks)
- Ocular surface disease index (OSDI) score(8 weeks and 12 weeks)
- Lipid layer thickness(8 weeks and 12 weeks)
- Ocular surface staining(8 weeks, 12 weeks)
研究者
Ing-Chou Lai, MD
Principal Investigator
Chang Gung Memorial Hospital