NCT03856645Unknown2 期
A Phase 2, Multi-centeR, Randomized, DoUBle-Masked, Placebo-Controlled StudY to Evaluate the Clinical Safety and Efficacy of OKG-0301 in the Treatment of Acute Adenoviral Conjunctivitis
Okogen6 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2019年2月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 219
- 试验地点
- 6
- 主要终点
- Mean change from baseline in viral titre levels in the study eye
研究概览
简要总结
Acute adenoviral conjunctivitis is a highly contagious, widespread endemic disease associated with frequent outbreaks, significant patient discomfort, lost productivity, and in some cases permanent visual compromise from long-term immune mediated sequelae. OKG-0301 is a novel ophthalmic solution with a potent ribonuclease that has broad-spectrum antiviral properties relevant for the treatment of acute adenoviral conjunctivitis. This randomized, double masked, multi-center Phase 2 study is being conducted entirely within Australia and is designed to support the safety and efficacy of OKG-0301 for the treatment of acute adenoviral conjunctivitis. The study intends to show superiority of OKG-0301 Ophthalmic Solution compared to vehicle for the primary efficacy endpoint of mean change from baseline in viral titre in patients with acute adenoviral conjunctivitis. Secondary efficacy endpoints including adenoviral eradication, clinical cure of acute adenoviral conjunctivitis, subepithelial infiltrates, other clinical signs and symptoms, and rate of cross-over infection to the other eye will also be assessed. Safety will also be evaluated.
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
- •Each patient MUST:
- •Be willing and able to provide informed consent either written, or if the patient is not able to read, provide consent as stipulated by local laws and Human Research Ethics Committee (HREC) guidelines.
- •Be willing and able to follow all instructions and attend all study visits.
- •Have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least 1 eye and the presence of both of the following minimal clinical signs in that same eye:
- •Bulbar conjunctival redness: a minimum grade of '1' on 0-3 scale
- •Watery ocular discharge: a minimum grade of '1' on a 0-3 scale
- •Patient reported presence of signs and symptoms consistent with adenoviral conjunctivitis equal to or less than 3 days in same eye prior to Visit
- •Have a positive AdenoPlus® test at Visit 1 in the same eye that meets the minimum 1+ grade for bulbar conjunctival redness and watery ocular discharge.
- •Be willing to discontinue contact lens wear for the duration of the study.
排除标准
- •Each patient MUST NOT:
- •Have known sensitivity or poor tolerance to any component of the study medications or diagnostics.
- •Have a history of ocular surgical intervention or trauma within 12 weeks prior to Visit 1 or planned for the period of the study.
- •Have presence of any active ocular inflammation (e.g., uveitis, allergic conjunctivitis, ocular rosacea, or iritis), other than acute adenoviral conjunctivitis.
- •Have clinical signs or presence of an ocular infection other than acute adenoviral conjunctivitis (e.g., bacterial, fungal or other ocular viral infection, such as herpes).
- •Have the presence of corneal subepithelial infiltrates at baseline.
- •Have a history of recurrent corneal erosion syndrome, ulcerative keratitis or dry eye, including meibomian gland dysfunction and other ocular surface diseases.
- •Have presence of blepharitis, lid abnormality, significant inflammation of the lid margin, or ptosis.
- •Have lacrimal duct obstruction in either eye.
- •Have presence of any other clinically significant findings during the slit lamp exam that may interfere with study parameters or otherwise confound the data as determined by the investigator
- •Have any clinically significant retinal or optic nerve findings (as observed in the non-dilated fundus exam) or prior diagnoses in either eye that may interfere with study parameters or otherwise confound the data as determined by the investigator).
- •Have used any topical ocular or systemic anti-viral or topical ocular or systemic corticosteroid within 7 days of enrollment and do not plan to start any topical ocular or systemic anti-viral during study duration. Inhaled, intranasal, and topical dermatologic steroids (except on the face) are allowed during the study.
- •Initiate or continue the use of warm or cold compresses for the duration of the trial.
- •Have used any topical ophthalmic solutions, including tear substitutes and diagnostics, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic solutions (including diagnostics, except as required by this protocol and antibiotics) for the duration of the study. In addition, if the patient has used an artificial tear or other topical ophthalmic formulated in a hydrogel within the past 72 hours.
- •Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test.
- •Have any uncontrolled (not on a stable regimen for the past 30 days) systemic disease or debilitating disease (e.g., cardiovascular disease, hypertension, diabetes, or cystic fibrosis) or taking medications known to impact the ocular surface and/or tear film.
- •Have a planned overnight hospitalization during the period of the study.
- •Have any uncontrolled (not on a stable regimen for the past 30 days) autoimmune disease or taking medications known to impact the ocular surface and/or tear film.
- •Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device.
- •Have a condition or a situation which, in the investigator's opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient's study participation.
- •Be unlikely to follow study instructions or to complete all required study visits or has a condition or situation that in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
研究组 & 干预措施
OKG-0301 0.012% w/v
Experimental
干预措施: OKG-0301 (Drug)
OKG-0301 0.03% w/v
Experimental
干预措施: OKG-0301 (Drug)
Vehicle Control
Placebo Comparator
干预措施: OKG-0301 (Drug)
结局指标
主要结局
Mean change from baseline in viral titre levels in the study eye
时间窗: Day 7
PFU
次要结局
- Clinical Cure as Measured by the Absence of Bulbar Conjunctival Injection(Day 4, 7 and 14)
- Clinical Cure as Measured by the Absence of Watery Conjunctival Discharge(Day 4, 7 and 14)
- Adenoviral eradication (CC-IFA)(Day 4, 7 and 14)
- Adenoviral eradication (PFU)(Day 4, 7 and 14)
- Severity of subepithelial infiltrates(Day 4, 7 and 14)
- The rate of cross-over infection(Day 4, 7 and 14)
研究者
研究点 (6)
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