NCT05816070已完成2 期
A Phase II, Multi-Center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW 1201 Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
A Phase 2, Multi-center, Randomized, Parallel Controlled Study to Evaluate the Clinical Efficacy and Safety of IVIEW-1201 (1.0% Povidone-Iodine) Gel Forming Ophthalmic Solution Compared to Ofloxacin Eye Drops in the Treatment of Acute Bacterial Conjunctivitis
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
- Single (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.
- •A diagnosis of acute bacterial conjunctivitis based on clinical observations:
- •a score of ≥1 for bulbar conjunctival congestion and ≥1 for conjunctival secretion/exudation in at least one eye (same eye);
- •increased purulent, mucopurulent or mucopurulent secretions are observed in the conjunctival sac of the affected eye in all patients.
- •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 (1.0% povidone iodine ophthalmic gel sterile solution) and Of laxacin Eye Drops; have a history of allergy or serious adverse reactions to quinolones; or have a cumulative total of three or more allergies to other drugs, food and environment; or who are prone to allergic symptoms such as rash and urticaria;
- •Symptoms or signs of bacterial conjunctivitis for more than 72 hours prior to screening;
- •Suspected fungal, viral or acanthamoeba infections based on clinical observations;
- •Those with severe keratitis or corneal opacity affecting the study results;
- •Active inflammation of the cornea, iris, or anterior chamber;
- •Corrected visual acuity of less than 0.2 in either eye;
- •History of eye surgery within 3 months prior to screening;
- •Those who have a history of acute or chronic dacryocystitis;
- •Those who need to wear corneal contact lenses during the trial;
- •Those who have used antibiotic eye drops or glucocorticoid eye drops within 14 days, and oral or intravenous antibiotics within 72 hours 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 7 days before enrollment (nasally or bronchially inhaled steroidal drugs are not allowed during the study);
- •Those with co-infections requiring treatment with other anti-infective drugs in the study;
- •Those who are using other drugs that may interfere with the efficacy or safety evaluation of the drug;
- •Participation in other interventional clinical trials within 30 days prior to the study;
- •Pregnant or lactating women, women with positive pregnancy tests and those planning to become pregnant (including male subjects); subjects who do 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
Ofloxacin Eye Drops
Active Comparator
干预措施: Ofloxacin Eye Drops (Drug)
IVIEW-1201
Experimental
干预措施: IVIEW-1201 (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: Take the visit 4 (Day 8±1) data, unless the subject was not cured and did not continue the treatment after visit 4 (Day 8±1) , in which case, visit 5 (Day 14±1) data would be used instead of Visit 4 data (Day 8±1).
The proportion of subjects with a score of 0 (0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for bulbar conjunctival congestion and 0 (0=Absent, 1=Mild, 2=Moderate, 3=Severe.) for conjunctival secretion/exudation at Visit 4 (Day 8±1), Visit 5 (Day 14±1).
次要结局
- Clearance Rate(Day 3, Day 6, Day 8±1, Day 14±1)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus ErythematosusDiscoid Lupus ErythematosusNCT05591222Amgen72
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
进行中（未招募）
2 期
Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPCNasopharyngeal Carcinoma by AJCC V8 StageNCT05513573Shanghai Henlius Biotech75
招募中
2 期
A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis BChronic Hepatitis BNCT06425341Fujian Shengdi Pharmaceutical Co., Ltd.369
尚未招募
2 期
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal KeratitisFungal KeratitisNCT06463678IVIEW Therapeutics Inc.60