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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Blepharitis
• Intervention / Treatment: Drug: Lotilaner; Drug: Vehicle Control

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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100005
      • Beijing Tongren Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400020
      • Chongqing Aier Eye Hospital
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Xiamen Eye Center of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510040
      • Guangzhou Aier Eye Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan Eye Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150007
      • The First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Provincial Eye Hospital
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430022
      • Union Hospital, Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University
    • Changsha, Hunan, China, 410007
      • The Second Xiangya Hospital Of Central South University
    • Hengyang, Hunan, China, 421001
      • The First Affiliated Hospital of University of South China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214002
      • Wuxi Second People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200940
      • Shanghai General Hospital
    • Shanghai, Shanghai, China, 200031
      • Eye& Ent Hospital of Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China, 030002
      • Shanxi Provincial Eye Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300392
      • Tianjin Medical University Eye Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The Second Affiliated Hospital Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hospital, Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lotilaner Ophthalmic Solution (TP-03)	Drug: Lotilaner; Lotilaner Ophthalmic Solution; Other Names: TP-03; S-Misoxam
Placebo Comparator: Vehicle Control	Drug: Vehicle Control; Vehicle of TP-03 ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The assessment of treatment-related adverse effects	To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis	43 days
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: LianBio LLC
• Investigators: Principal Investigator: Zuguo Liu, M.D, Xiamen Eye Center of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Blepharitis
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharitis
• Other Study ID Numbers: LB4001-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No