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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05629390
Other study ID # LB4001-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 23, 2022
Est. completion date April 2, 2024

Study information

Verified date May 2024
Source LianBio LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The main study is designed to demonstrate the superiority of TP-03 compared to vehicle for the treatment of Demodex blepharitis in Chinese patients. The vehicle of TP-03 was selected as the control since there are no approved pharmaceutical treatments for Demodex blepharitis. The vehicle as the control will provide evidence that the active ingredient is responsible for the response, not the vehicle alone. A pharmacokinetics (PK) sub-study is included in the overall study design to evaluate systemic PK parameters of TP-03 in Chinese participants with Demodex blepharitis. The PK sub-study sites are separate from those of the Phase III study as described above.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lotilaner
Lotilaner Ophthalmic Solution
Vehicle Control
Vehicle of TP-03 ophthalmic solution

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
LianBio LLC

Country where clinical trial is conducted

China, 

Outcome

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
See also
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