Clinical trial NCT05629390: Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blepharitis
Keywords: Blepharitis
Lead sponsor: LianBio LLC
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.
timeFrame: 43 days
measure: The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43
timeFrame: 43 days
measure: The assessment of treatment-related adverse effects
timeFrame: 43 days
Secondary outcomes:
measure: 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
timeFrame: 43 days
measure: Blood drug concentration of Lotilaner at Day 43
timeFrame: 43 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Aier Eye Hospital
state: Chongqing
city: Xiamen
country: China
facility: Xiamen Eye Center of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou Aier Eye Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Haikou
country: China
facility: Hainan Eye Hospital
state: Hainan
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial Eye Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Eye& Ent Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Eye Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Xiamen Eye Center of Xiamen University
name: Zuguo Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References: