Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629390
• Other study ID #: LB4001-301
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Blepharitis

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