Analysis of comparative efficacy of a combination formula for a lubricant (Trehalose with sodium hyaluronate 1mg/mL) in the management of ocular surface conditions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it
研究概览
简要总结
Dry eye disease is a multifactorial disease of the ocular surface associated with symptoms of dryness and visual disturbances.
Study conducting for following parameters analysis
1. The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it
2. The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in moderate to severe dry eye and the effect of various topical eye medications on it
3. To study the differences in the performance of these medications in dry eye using various dry eye evaluation techniques.
4. To study the corneal nerve regeneration after laser refractive surgery on Confocal microscopy
5. To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathways
6. To study the mechanism of action of the drugs in the management of dry eye.
| Primary/co-primary Endpoint(s) |
Improvement in signs and symptoms of dry eye
|Secondary Endpoint
Reduction of inflammatory cytokine levels in tears
|Safety Endpoint
No inflammation or adverse reaction post treatment.
|
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and Females 2.Age 18 to 65 years, 3.Mild to moderate dry eye disease as per: i.OSDI score >18 ii.Schirmers II (with anaesthesia) >5 at 5 minutes, < 10 at 5 minutes iii.TBUT < 7 seconds iv.Corneal and conjunctival staining ( graded by NEI and Van Bjisterveld grading) 4.No use of any tear substitute for either eye in the preceding 6 weeks 5.Willing to participate in the study Inclusion criteria for Arm 2: 6.All patients undergoing corneal refractive surgery without pre-existing dry eye 7.Willing to participate in the study.
排除标准
- •1.BCVA distance < 6/60 2.Severe blepharitis 3.Eyelid malposition 4.Corneal scar/ opacity 5.Ocular Surface Squamous neoplasia (OSSN) 6.Corneal neovascularisation or pannus 7.cular allergy (except in paediatric population) 8.Any ocular infection in the past 3 months 9.Cataract surgery in the past 3 months 10.Corneal or conjunctival procedure 11.Ocular medications which are known to worsen dry eye like AGM 12.Systemic conditions like collagen vascular disease, rheumatoid arthritis, Steven Johnson syndrome Exclusion criteria for arm 2 13.Pre-existing dry eye 14.Corneal neovascularisation or pannus 15.Ocular allergy (except in paediatric population) 16.Any ocular infection in the past 3 months.
结局指标
主要结局
1.The changes in various ocular surface signs and symptoms and quantitative and qualitative analysis of tear film in dry eye induced secondary to laser refractive surgery and effect of various topical eye medications on it
时间窗: 10 days, 1 month, 3 months and 6 months
次要结局
- To study the inflammatory pathways involved in dry eye and action of each of the medications on those pathways(6 Months)