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

NCT ID: NCT05629390

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2024-04-02

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.

Conditions

Blepharitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lotilaner Ophthalmic Solution (TP-03)

Lotilaner Ophthalmic Solution (TP-03)

Group Type: EXPERIMENTAL

Lotilaner

Intervention Type: DRUG

Lotilaner Ophthalmic Solution

Vehicle Control

Vehicle Control

Group Type: PLACEBO_COMPARATOR

Vehicle Control

Intervention Type: DRUG

Vehicle of TP-03 ophthalmic solution

Interventions

Lotilaner

Lotilaner Ophthalmic Solution

Intervention Type: DRUG

Vehicle Control

Vehicle of TP-03 ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

TP-03; S-Misoxam

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LianBio LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zuguo Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

Xiamen Eye Center of Xiamen University

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing Aier Eye Hospital

Chongqing, Chongqing Municipality, China

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, 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 First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Henan Provincial Eye Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Wuxi Second People's Hospital

Wuxi, Jiangsu, China

Eye& Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Eye Hospital

Taiyuan, Shanxi, China

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

LB4001-301

Identifier Type: -

Identifier Source: org_study_id