NCT05629364终止2 期
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, Versus Vehicle Control in the Treatment of Dry Eye Disease in Patients With Autoimmune Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Schirmer's 1 test
研究概览
简要总结
A Multi-Centre, Randomised, Controlled, Masked Phase 2 Study of the Safety and Efficacy of KIO-101 Ophthalmic Solution, versus Vehicle Control in the treatment of Dry Eye Disease in Patients with Autoimmune Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of autoimmune disease (psoriatic arthritis, Systemic Lupus Erythematosus (SLE), or fibromyalgia) ≤ 10 years
- •Have an Ocular Discomfort Score (ODS) score of ≥3 at Screening
- •Have an average VAS score ≥ 50 at Screening; and ≥ 40 at Baseline, Visit 2/Day 1
- •Schirmer's 1 test >1 but < 10 mm at Screening.
- •National Eye Institute (NEI) corneal fluorescein staining score of ≥ 4 at Screening (Day 14) provided that the total NEI score did not change > ± 2 grades from Screening (Day -14) to Baseline (Day 1) visits, as confirmed by the investigator
- •Have a Best Spectacle Corrected Visual Accuity (BSCVA) score of 20/200 (+1.0 LogMAR) or better in both eyes at both the Screening and Baseline visits
- •Have a conjunctival hyperaemia score of Grade 2 or more on the Efron Scale in both eyes
排除标准
- •Have a history or presence of any ocular disorder or condition (other than dry eye disease (DED)) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
- •Have an autoimmune based vasculitis
- •Have a history of RA > 10 years.
- •Have a Schirmer's 1 test score of 0 to 1mm at Screening
- •Have had a corneal transplant in either or both eyes
- •Have had puncta or intracanalicular plug present in either eyelid within 1 year prior to the Screening Visit or anticipated plug insertion or occlusion at any time during the study
研究组 & 干预措施
0.15% KIO-101
Experimental
.15% KIO-101 eyedrops
干预措施: KIO-101 (Drug)
0.3% KIO-101
Experimental
0.3% KIO-101 eyedrops
干预措施: KIO-101 (Drug)
Vehicle
Placebo Comparator
Vehicle eyedrops
干预措施: KIO-101 (Drug)
结局指标
主要结局
Change in Schirmer's 1 test
时间窗: 12 weeks
Change from Baseline to Week 12 for Schirmer's 1 test
次要结局
未报告次要终点
研究者
研究点 (1)
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