Efficacy of 0.28% Sodium Hyaluronate Eye Drops in Patient with Moderate to Severe Dry Eye : a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of 0.28% preservative-free SH and 0.18% SH eye drops in patients with dry eye disease. Subjects diagnosed with dry eye disease and meeting the inclusion criteria (Ocular Surface Disease Index (OSDI) score ≥ 23, Fluorescein Tear Breakup Time (TBUT) < 7 seconds were randomized into two groups. Group 1 (42 eyes) received 0.28% SH, and Group 2 (42 eyes) received 0.18% SH, both administered by a nurse. Measurements included tear osmolarity (TearLAB) before instillation and at 0,30 and 60 minutes post-instillation, recorded by a TearLAB specialist. Ophthalmologists assessed TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation and evaluated adverse reactions up to 60 minutes post-instillation. Subjects continued treatment for 30 days and were reevaluated during a second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events. Quality of life score were assessed at before and after treatment for 1 month.
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)
盲法说明
The nurse will randomly assign eligible patients to receive either 0.28% sodium hyaluronate eye drops (Vismax®) or 0.18% sodium hyaluronate eye drops (Vislube®) using a computerized randomsation. The nurse will be the only individual informed of the assigned medication and will be responsible for administering the eye drops to the participants.
Additionally, the nurse will prepare a medication for the patient to take home. TearLAB specialists measured and recorded tear osmolarity before instillation in all cases for 10 minutes, and at 30 and 60 minutes post-instillation. Ophthalmologists evaluated TBUT, ocular surface staining (Oxford grading scale), and the Schirmer I test before instillation for 5 minutes and assessed adverse reactions up to 60 minutes after instillation. Subjects continued treatment for 30 days and were reevaluated during the second visit for OSDI scores, TBUT, the Oxford grading scale, and adverse events.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age more than or equal 18 year-old
- •Ocular Surface Disease Index (OSDI) more than or equal 23
- •Oxford grading scale more than or equal 2 (both eye)
- •Fluorescein tear break-up time less than 7 seconds (both eyes)
- •Willing to being a subject in research.
排除标准
- •Diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as Glaucoma
- •History of Ocular surgery in previous 3 months or Refractive surgery in previous 6 months
- •History of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months
- •Wear contact lenses
- •Allergic to Sodium hyaluronate
- •Pregnant or lactation period
- •Diagnosed with physical diseases that affect the eyes and cannot yet be controlled, such as uncontrolled DM (Diabetes Mellitus), active autoimmune disease, and systemic neuropathy induced neurotrophic keratopathy. - Continuous use of medications for diseases such as Retinoic acid derivatives, Antihistamines, Cholinergic agents, and Antipsychotic agents which can lead to chronic dry eye
- •Incompleted data.
研究组 & 干预措施
Vismax
0.28% Sodium Hyaluronate , preservative free eye drops
干预措施: 0.28% Sodium Hyaluronate , preservative free eye drops (Drug)
Vislube
0.18% Sodium Hyaluronate , preservative free eye drops
干预措施: 0.18% Sodium Hyaluronate , preservative free eye drops (Drug)
结局指标
主要结局
To examine the effect of 0.28% Sodium Hyaluronate on corneal epithelial healing
时间窗: 30 days
The Oxford grading scale was used. This scale consists of six levels: 0, I, II, III, IV, and V, with higher values indicating more severe punctate epithelial erosion.
To examine the effect of 0.28% Sodium Hyaluronate on reducing tear osmolarity
时间窗: 60 minutes
Tear osmolarity was monitored before and after the intervention in both arms. Abnormal Tear Osmolarity is defined as a value of ≥ 308 mOsmol/L, measured using the TearLab® system.
次要结局
- 3. To study the stability of the tear film following the administration of 0.28% Sodium Hyaluronate(0 minutes, 60 minutes, and 30 days.)
- To assess dry eye symptoms following the administration of 0.28% Sodium Hyaluronate(0 minutes and 30 days.)
- To assess quality of life following the administration of 0.28% Sodium Hyaluronate(0 minutes and 30 days.)