Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye: A Randomized, Single-Blind, Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lipid layer thickness (LLT)
研究概览
简要总结
The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.
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, Care Provider)
盲法说明
0.20% Cross-linked hyaluronic acid tear substitute and 0.15% hyaluronic acid tear substitute are transparent, with no special smell and the bottles were identical in appearance such that patients, investigators and care provider were masked to treatment assignment.
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
- •Self-reported history DED.
- •Ocular surface disease index (OSDI) > 13 points.
- •Non-invasive tear film break-up time (NIBUT) < 10 s.
- •Schirmer test (ST) without anesthesia ≥ 5 mm.
- •MGD grade >
- •For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG < 25%; MGD grade 2 = LAMG ≥ 25% and < 50%; MGD grade 3 = LAMG ≥ 50% and < 75%; MGD grade 4 = LAMG ≥ 75%).
排除标准
- •Abnormal lid anatomy, including active blepharitis, and active lid margin.
- •All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
- •Active ocular allergies.
- •Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
- •Intraocular surgery or laser ocular surgery within the previous 6 months.
- •Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
- •Systemic autoimmune diseases.
- •Contact lens wearers.
- •Pregnant or lactating women.
- •Patients who did not understand or comprehend the informed consent.
研究组 & 干预措施
Cross-linked hyaluronic acid
Tear substitute based on 0.20% Cross-linked hyaluronic acid
干预措施: Icross tear substitute (Drug)
Hyaluronic acid
Tear substitute based on 0.15% Cross-linked hyaluronic acid
干预措施: Hyabak tear substitute (Drug)
结局指标
主要结局
Lipid layer thickness (LLT)
时间窗: This outcome measure was analyzed at baseline, 1 months and 3 months.
The Lipiview® (Johnson \& JohsonVision Care, San Francisco, CA, USA) II ocular surface interferometer evaluates LLT automatically assesses LLT with nanometer precision by recording a 20 s video of the tear film interference pattern and then displays the data in interferometric color units (ICU), where1 ICU reflects approximately 1 nm of LLT.
次要结局
- Ocular surface disease index questionnaire(This outcome measure was analyzed at baseline, 1 months and 3 months.)
- Non-invasive tear film break-up time(This outcome measure was analyzed at baseline, 1 months and 3 months.)
- Schirmer I test without anesthesia(This outcome measure was analyzed at baseline, 1 months and 3 months.)
研究者
José-María Sánchez-González
Clinical professor
University of Seville