Blepharitis Clinical Trial
Official title:
Randomized Controlled, Multicenter, Double-Masked, Parallel Phase III Trial to Evaluate the Efficacy and Safety of Lotilaner Ophthalmic Solution for the Treatment of Demodex Blepharitis in China With an Open-Label Pharmacokinetics Sub-Study
Verified date | May 2024 |
Source | LianBio LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Phase III main study is a randomized, controlled, multicenter, double blind, trial to evaluate the efficacy and safety of TP-03 (lotilaner ophthalmic solution, 0.25%), for the treatment of Demodex blepharitis in Chinese patients. The PK sub-study is a single-arm, open-label trial to evaluate systemic TP-03 in whole blood following topical ocular administration
Status | Completed |
Enrollment | 163 |
Est. completion date | April 2, 2024 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Male or female, aged = 18 years of age. 2. Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. 3. Has blepharitis 4. Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: 1. Have used lid hygiene products (e.g., lid scrubs) within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study. 2. Have initiated treatment with an ocular topical prostaglandin analogue within 30 days of Screening or have any plans to change or discontinue treatment during the study 3. Pregnancy or lactation. 4. Any intraocular surgery (including ocular surface surgery, cataract surgery and intravitreal injection) or periocular surgery within 60 days prior to randomization, or any planned ocular surgical procedure during the study period 5. Have any unstable or uncontrolled, cardiac, pulmonary, renal, oncological, neurological, metabolic or other systemic condition that, in the opinion of the investigator, would possibly require the participant to seek emergent medical treatment during the course of this study. This includes, but is not limited to, unstable or uncontrolled cardiac arrhythmias, hypertension, coagulopathies, renal failure or advanced diabetes mellitus. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tongren Hospital | Beijing | Beijing |
China | Peking University Third Hospital | Beijing | Beijing |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | Xiangya Hospital, Central South University | Changsha | Hunan |
China | Chongqing Aier Eye Hospital | Chongqing | Chongqing |
China | Guangzhou Aier Eye Hospital | Guangzhou | Guangdong |
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
China | Hainan Eye Hospital | Haikou | Hainan |
China | The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
China | Eye& Ent Hospital of Fudan University | Shanghai | Shanghai |
China | Shanghai General Hospital | Shanghai | Shanghai |
China | Shanxi Provincial Eye Hospital | Taiyuan | Shanxi |
China | Tianjin Medical University Eye Hospital | Tianjin | Tianjin |
China | Eye Hospital, Wenzhou Medical University | Wenzhou | Zhejiang |
China | Renmin Hospital of Wuhan University | Wuhan | Hubei |
China | Union Hospital, Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei |
China | Wuxi Second People's Hospital | Wuxi | Jiangsu |
China | Xiamen Eye Center of Xiamen University | Xiamen | Fujian |
China | Henan Provincial Eye Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
LianBio LLC |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye. | To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis | 43 days | |
Primary | The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43 | To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis | 43 days | |
Primary | The assessment of treatment-related adverse effects | To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis | 43 days | |
Secondary | The proportion of participants cured based on a composite of collarette score of 0 and erythema score of 0 for the upper eyelid of the analysis eye | To demonstrate the efficacy of TP-03 to eliminate collarettes and erythema from the eyelid margin | 43 days | |
Secondary | Blood drug concentration of Lotilaner at Day 43 | To evaluate the blood drug concentration of Lotilaner following topical ocular administration of TP-03administration of 0.25% TP-03 | 43 days |
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