A Phase 3 Randomized, Multi-Center, Placebo-Controlled, Masked Study to Evaluate the Clinical Efficacy and Safety of Fusidic Acid 1% Viscous Topical Antibiotic Eye Drops for the Treatment of Suspected Bacterial Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 65
- 主要终点
- Clinical Cure
研究概览
简要总结
The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
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, Care Provider, Investigator)
盲法说明
All study staff (Sponsor, Site and Contract Research Organization (CRO)) involved in the day to day activities of the study are masked. Each site will have a designated unmasked dosing coordinator and the Sponsor/CRO will have an unmasked team member(s) as well, who is not involved in study conduct (e.g., for investigational product or statistical activities that require an unmasked individual).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye, confirmed by the presence of purulent or mucopurulent ocular discharge and a grade ≥ 1 on the modified Validated Bulbar Redness (VBR) conjunctival redness scale.
- •Have not received any ocular treatment for conjunctivitis, aside from eyelid hygiene, ≤14 days prior to Visit
- •Have a negative viral conjunctivitis test in both eyes.
- •Agree to discontinue use of eye/eyelid cosmetics during study participation.
- •Agree to discontinue use of contact lenses during study participation.
- •Be willing and able to provide informed consent and comply with the study requirements.
- •Not be currently pregnant or breastfeeding. If sexually active, agree to use approved contraception for the duration of the study.
排除标准
- •Have signs and/or symptoms or a diagnosis of fungal, protozoal, or viral etiology ≤30 days prior to Visit
- •Have experienced signs and symptoms of bacterial conjunctivitis for >48 hours prior to Visit
- •Require or are expected to require use of any non-study topical ocular medication or systemic medications prior to Visit 1 as specified in the protocol as ineligible.
- •Have any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
- •Have a known intolerance, sensitivity or allergy to the study medications or any of their components.
- •Have participated in another clinical trial ≤30 days or received another experimental drug ≤90 days prior to Visit
- •Have a family member or household member enrolled in this study.
- •Have a condition which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
- •Be an employee of or immediate family member of an employee (directly related to study conduct) at the study site.
研究组 & 干预措施
Fusidic Acid 1%
Participants will instill one drop of fusidic acid 1% per eye twice a day (BID) for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing
干预措施: Fusidic Acid 1% (Drug)
Placebo
Participants will instill one drop of Placebo ophthalmic solution per eye BID for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure
时间窗: Visit 2 (Day 4)
Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure.
次要结局
- Microbial Eradication(Visit 3 (Day 8))
- Clinical Cure(Visit 3 (Day 8))