Modified Sodium Hyaluronate Conjugated to Riboflavin (HAr® 0.1%) as Lubricant Eyedrops in the Treatment of Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy and safety of a new 0.1% sodium hyaluronate-riboflavin-conjugated (HAr®) artificial tear in treating ocular discomfort and improving tear film stability in patients with dry eye disease.
研究概览
简要总结
The goal of this retrospective study is to evaluate the historical effectiveness of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED) among patients. The product under investigation, Ribohyal®, had previously obtained certification and authorization from the relevant notified body for market sale (European patent n. 2228058)
The primary questions it aimed to address were:
- Did the use of Riboflavin-Enhanced Hyaluronic Acid Eye Drops result in a reduction of dry eye symptoms and an improvement in ocular comfort among patients with DED in a historical context?
- Was Riboflavin-Enhanced Hyaluronic Acid Eye Drops historically more effective in reducing photophobia and enhancing tear film stability when compared to standard treatment?
Participants in this retrospective analysis had historically:
- Used either Riboflavin-Enhanced Hyaluronic Acid Eye Drops or a standard hyaluronic acid eye drop, based on their assigned group.
- Historically reported their levels of ocular discomfort and photophobia at specified time points.
- Undergone historical clinical examinations to assess tear film stability and osmolarity.
Researchers conducted a retrospective analysis to compare the historical outcomes of the group using Riboflavin-Enhanced Hyaluronic Acid Eye Drops with the group using standard eye drops to determine if the former historically provided more significant improvements in dry eye symptoms and tear film stability.
详细描述
In this retrospective study, the investigators have examined the historical therapeutic efficacy of Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) in the treatment of Dry Eye Disease (DED), adhering to good clinical practice principles.
Participants were historically divided into two groups:
- Group X: received Riboflavin-Enhanced Hyaluronic Acid Eye Drops (HAr® 0.1%) (Ribohyal Group).
- Group Y: received standard HA 0.1% eye drops (Control Group).
The historical outcome measures included the retrospective assessments of osmolarity, Tear Break-Up Time (TBUT), corneal staining, Schirmer test, tear meniscus measurement, and Non-invasive Break-Up Time (NIBUT). The Ocular Surface Disease Index (OSDI) score was historically recorded at various time points.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •Age below 18 years
- •Severe ocular surface affections
- •Unilateral dry eye syndrome
- •Refractive surgery performed within the last six months
- •Eye surgery performed within the last three months
- •Previous herpetic keratitis
- •Signs of active corneal infection
- •Systemic or topical steroid therapy within the last 30 days
- •Topical therapy within the last 14 days
- •Inability to understand the informed consent.
研究组 & 干预措施
Group X: Ribohyal Group
Composed of 16 eyes (right or left) assigned for the use of modified hyaluronic acid, HAr® 0.1%, covalently linked to Riboflavin
干预措施: modified hyaluronic acid 0.1% covalently linked to Riboflavin (Drug)
Group Y: (Control Group)
Composed of 16 eyes (right or left) assigned for the use of HA 0.1% alone
干预措施: hyaluronic acid 0.1% (Drug)
结局指标
主要结局
Evaluate the efficacy and safety of a new 0.1% sodium hyaluronate-riboflavin-conjugated (HAr®) artificial tear in treating ocular discomfort and improving tear film stability in patients with dry eye disease.
时间窗: From enrollment to the end of treatment at 8 weeks
Ocular discomfort reduction mesured by OSDI test.
次要结局
- Evaluate the reduction in Tear osmolarity(From enrollment to the end of treatment at 8 weeks)
- Measure the stability of the tear film(From enrollment to the end of treatment at 8 weeks)
- Measure the tear production(From enrollment to the end of treatment at 8 weeks)
- Evaluate corneal staining(From enrollment to the end of treatment at 8 weeks)
研究者
Luca D'Andrea
Prinicipal investigator
Federico II University