Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease: A Randomized, Double-blinded, HA-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Ocular surface disease index questionnaire
研究概览
简要总结
The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.
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)
盲法说明
TriMix tear substitute and 0.15% HA 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 while working with computer screens ≥ 6 hours per day.
- •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
TriMix
A new-generation tear substitute containing cross-linked hyaluronic acid 0.15%, trehalose 3%, liposomes 1% and sterylamine 0.25%.
干预措施: Trimix tear substitutes (Drug)
Hyaluronic acid
0.15% Hyaluronic acid tear substitute.
干预措施: Hyaluronic acid tear substitute (Drug)
结局指标
主要结局
Ocular surface disease index questionnaire
时间窗: This outcome measure was analyzed at baseline, 3 months and 6 months.
The OSDI questionnaire were employed to assess the severity of DED symptoms, with scores ranging from 0 (indicating no ocular surface disease) to 100 (indicating severe ocular surface disease) points. This questionnaire was provided during consultations at each follow-up visit.
Non-invasive tear film break-up time
时间窗: This outcome measure was analyzed at baseline, 3 months and 6 months.
Tear film stability was automatically assessed using NIBUT by projecting Placido rings from the Sirius device (CSO, Florence, Italy) onto the corneal surface. The time interval between the last blink and the initial distortion of the ring pattern was defined as first NIBUT. This variable was always measured at least 12 hours after administration of the study medication and the average of 3 consecutive measurements was calculated for statistical analysis.
Schirmer I test without anesthesia
时间窗: This outcome measure was analyzed at baseline, 3 months and 6 months.
During the test, the patient is instructed to look upward while the test strip is carefully positioned between the palpebral conjunctiva of the lower eyelid and the bulbar conjunctiva. Subsequently, the patient is asked to keep their eyes gently closed for five minutes. After this period, the test strip is removed, and the Schirmer test score is determined by measuring the length of the moistened area on the strip.
次要结局
未报告次要终点
研究者
José-María Sánchez-González
OD, PhD
University of Seville