NCT07285070招募中2 期
A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05) for the Treatment of Non-Infectious Anterior Uveitis
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Novaliq GmbH
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Adverse Events
研究概览
简要总结
The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.
详细描述
This first in-human, phase 2 proof of concept study aims to show that the formulation at two concentrations is safe and well tolerated over a period of 6 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥18 years of age;
- •Provide written informed consent;
- •Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
- •Have an onset of symptoms within 4 weeks;
排除标准
- •Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of the clinical Investigator;
- •Have a history of or a current ocular or periocular malignancy;
- •Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
- •A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
- •Have a known allergy or sensitivity to the IMP tacrolimus or semifluorinated alkanes (SFA);
- •Be a woman who is pregnant, nursing, or planning a pregnancy;
- •Have a condition or be in a situation (e.g. language barrier, non-cooperative, history of substance abuse) which the Investigator considers that it may put the patient at significant risk, may confound the trial results, or may significantly interfere with the patient's participation in the trial;
研究组 & 干预措施
Tacrolimus ophthalmic solution (high dose)
Active Comparator
干预措施: Tacrolimus ophthalmic solution (Drug)
Tacrolimus ophthalmic solution (low dose)
Active Comparator
干预措施: Tacrolimus ophthalmic solution (Drug)
结局指标
主要结局
Adverse Events
时间窗: 8 weeks
ocular and non-ocular adverse events
次要结局
未报告次要终点
研究者
研究点 (6)
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