NCT06463678尚未招募2 期
A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Clinical cure rate
研究概览
简要总结
A Phase II, Multi-center, Randomized, Masked, Parallel-Control Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel Forming Ophthalmic Solution in the Treatment of Fungal Keratitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteered to participate in the study and signed the Informed Consent Form after receiving a verbal and written explanation of this clinical trial. In cases where the subject is unable to sign the Informed Consent Form, his/her guardian may sign in accordance with relevant regulations.
- •Aged above 15 (inclusive), male or female.
- •Preliminary diagnosis of fungal keratitis based on medical history and clinical observations: corneal focus score ≥
- •Fungal infection confirmed by laboratory tests (positive for any of the three: fungal hyphae on scraping examination, fungal hyphae on confocal microscopy, positive fungal culture).
- •Not treated with antifungal drugs within 48 hours.
- •Willing to cooperate in the completion of all procedures and visits required for the trial.
排除标准
- •Patients with systemic or ocular diseases, or functional disorders with comorbidities, or structural abnormalities that, in the judgment of the investigator, could adversely affect the course or results of the trial (e.g., hyperthyroidism, hepatitis, acute and chronic renal insufficiency).
- •Those who have a history of allergy or serious adverse reactions to any component of IVIEW-1201 and NATACYN®; a history of allergy or serious adverse reactions to polyene macrolides and other antifungal drugs; or have a cumulative total of three or more allergies to other drugs, food and environment; or have a predisposition to allergic symptoms such as rash or urticaria.
- •Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction and patients with life-threatening or severe unstable underlying diseases.
- •Those with other combined infectious ocular surface diseases.
- •Those with sclera involvement.
- •Those with combined corneal perforation or imminent perforation.
- •Patients with glaucoma and corneal limbal stem cell abnormalities that cannot be cured at the same time, severe chemical burns of cornea and conjunctiva, corneal foreign bodies and other diseases not suitable for this trial.
- •Those who would need to wear corneal contact lenses during the trial.
- •Those who add other medications to treat fungal infections during the trial (except non-facial local treatment).
- •Those who are using other drugs that may interfere with the efficacy or safety evaluation of IVIEW-
- •Systemic use of antifungal drugs within 14 days prior to screening.
- •Systemic use of steroidal drugs within 14 days prior to screening. Local use of eye steroidal drugs or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days before enrollment (nasally or bronchially inhaled steroidal drugs are not allowed at any time during the trial).
- •Participation in other interventional clinical trials within 30 days prior to the trial.
- •Pregnant or lactating women, women with positive blood or urine pregnancy tests and those planning to become pregnant (including male subjects); subjects who did not take effective contraceptive measures within 1 month before enrollment, or subjects (including male subjects) who are unwilling to take effective contraceptive measures within the next 6 months.
- •Other conditions or illnesses judged by the clinical investigator to be unsuitable for enrollment.
研究组 & 干预措施
IVIEW-1201
Experimental
干预措施: IVIEW-1201 (Drug)
NATACYN®
Active Comparator
干预措施: NATACYN® (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: Day 29 ± 1 day
Proportion of subjects with a score of 0/12. This is manifested by the resolution of clinical symptoms, healing of corneal ulcers, negative fluorescein staining, corneal recovery to translucency or transparency, and resolution of hypopyon.
次要结局
- Fungal clearance(Day 29 ± 1 day)
- Best-corrected visual acuity(Baseline (Day 1) and Day 29 ± 1 day)
研究者
相似试验
已完成
2 期
Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular EdemaDiabetic Macular EdemaNCT02348918Allegro Ophthalmics, LLC218
已完成
2 期
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial ConjunctivitisAcute Bacterial ConjunctivitisNCT05816070IVIEW Therapeutics Inc.129
已完成
2 期
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral ConjunctivitisAdenoviral ConjunctivitisNCT03749317IVIEW Therapeutics Inc.135
已完成
2 期
A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLCNon Small Cell Lung CancerNCT05519865Chipscreen Biosciences, Ltd.118
已完成
2 期
Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening InfluenzaInfluenzaNCT00453999BioCryst Pharmaceuticals137