NCT07443202Enrolling By Invitation2 期
A Randomized, Vehicle-Controlled, Multicenter, Double-Masked, Parallel, Phase 2 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of Lotilaner Ophthalmic Gel in Participants With Ocular Rosacea (KORE)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Incidence of Treatment Emergent Adverse Events
研究概览
简要总结
To evaluate lotilaner treatment in patients with ocular rosacea.
详细描述
To evaluate safety of lotilaner compared to vehicle control in the treatment of ocular rosacea.
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
- •18 years of age or older at the time of consent.
- •Has moderate to severe ocular rosacea
- •Use of acceptable methods of contraception
- •Are willing to sign the informed consent form and is deemed capable of complying with the requirements of the study protocol
排除标准
- •Patient taking a topical or other therapy which may affect the patients rosacea
- •Actively managed glaucoma or active ocular infection or ocular systemic disease
- •Have hypersensitivity to lotilaner or any of the formulation components
- •Are currently enrolled in an investigational drug or device study
- •Are currently pregnant or lactating or planning to become pregnant during the study
研究组 & 干预措施
Control arm
Other
Vehicle of lotilaner - high dose and low dose
干预措施: Vehicle (Drug)
Treatment arm
Experimental
lotilaner - high dose and low dose
干预措施: lotilaner (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events
时间窗: Week 16
Number of patients with treatment related emergent adverse events (TEAEs)
次要结局
- Visual acuity(Week 16)
- Intraocular pressure(Week 16)
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
A Study to Evaluate the Use of Topical Ocular BL1332 for the Management of Postoperative Ocular Pain Following Photorefractive KeratectomyNCT07412496Bausch & Lomb Incorporated123
已完成
不适用
Efficacy and Safety of Livalozet® in Hypercholesterolemic Patients With and Without DiabetesHypercholesterolemiaNCT07382778JW Pharmaceutical1,538
尚未招募
1 期
A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious UveitisNCT07427628Quan Dong Nguyen18
尚未招募
不适用
A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver TransplantationHepatocellular CarcinomaNCT07310836Ningbo Medical Center Lihuili Hospital300
尚未招募
不适用
A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaNCT07368023Ningbo Medical Center Lihuili Hospital300