Evaluate Efficacy, Safety, and Patient Perception of Sodium Hyaluronate and Trehalose eye drops with Mild to Moderate Dry Eye Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in OSDI score from baseline
研究概览
简要总结
This is a Phase 4, open-label, single-arm, single-center, post-marketing study designed to assess the efficacy and safety of Sodium Hyaluronate and Trehalose ophthalmic solution in patients with mild to moderate dry eye disease. The study consists of an 8-week treatment period.
In this study, the mean change in OSDI score from baseline to Week 2, Week 4, and Week 8 is determined as the primary efficacy endpoint.
The secondary endpoints include mean change in Ocular Surface Analyzer (OSA) parameters—Non-Invasive Tear Break-Up Time (NIBUT), Lipid Layer Thickness (LLT), Tear Meniscus Height (TMH), and Meibomian Gland (MG) loss—from baseline to Week 4 and Week 8, as well as the patient perception score regarding comfort and usability of the eye drops.
Safety endpoints include clinically significant changes in ocular examinations and the incidence and nature of adverse events (AEs) observed during the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to participate in the study and must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study Male or female Age of above 18 years (completed years) at the time of signing the informed consent.
- •Patients with an OSDI score between 13 and
- •Treatment naïve patients No history of ocular surgery within the last 6 months.
- •No systemic diseases affecting tear production.
- •History of allergic reactions to any component of the study medication Concurrent use of other ocular medications that could interfere with study outcomes.
排除标准
- •History of allergic reactions to any component of the study medication Concurrent use of other ocular medications that could interfere with study outcomes.
结局指标
主要结局
Mean change in OSDI score from baseline
时间窗: week 8
次要结局
- Mean change in OSA test ( NIBUT, LLT, TMH, and MG loss) from baseline(week 4 and 8)
- Improvemnt in Patient perception score(week 8)
- Clinically significant changes in ocular examination(During study period)
- Incidence and nature of adverse events(During study period)
研究者
Dr Gautam Parmar
Sadguru Netra Chikitsalaya