A Multicenter, Randomized, Double-blinded, Non-inferiority Phase 3 Study to Evaluate the Efficacy and Safety of HUC3-053 Compared With Hyalein Mini Eye Drops in Patients With Dry Eye Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Change from Baseline in Corneal staining score
研究概览
简要总结
This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.
After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Eye Drops administered bilaterally five to six times a day for 12 weeks.
详细描述
This is a multi-center, randomized, double-blinded, non-inferiority study to evaluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.
During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Eye Drops given bilaterally five to six times a day. The treatment period is 12 weeks.
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)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19
- •Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
- •Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
- •Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit
排除标准
- •The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
- •SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c>9%
- •Wearing contact lenses within 72 hr of screening visit
- •Pregnancy or Breastfeeding
研究组 & 干预措施
HUC3-053
Participants received "HUC3-053" in each eye five to six times a day for 12 weeks.
干预措施: HA 0.3% (Drug)
Hyalein Mini Eye Drops
Participants received "Hyalein Mini Eye Drops" in each eye five to six times a day for 12 weeks.
干预措施: Hyalein Mini Eye Drops (Drug)
结局指标
主要结局
Change from Baseline in Corneal staining score
时间窗: Week 12
Change from Baseline in Corneal staining score at week 12
次要结局
- Change from Baseline in Schirmer test(Week 4, 8, 12)
- Change from Baseline in Corneal staining score(Week 4, 8)
- Change from Baseline in Conjunctival staining score(Week 4, 8, 12)
- Change from Baseline in Tear film break-up time(Week 4, 8, 12)
- Change from Baseline in Eye Soreness after eye drop assessed by NRS(Week 4, 8, 12)
- Change from Baseline in Ocular surface disease index(Week 4, 8, 12)