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

NCT05629390 | Completed Phase 3

• 1 other identifier: LB4001-301
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 21

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

Conditions

Blepharitis

Keywords

Blepharitis

Outcome Measures

Primary Outcomes (3)

• 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

• The assessment of treatment-related adverse effects

  To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis

  43 days

Secondary Outcomes (2)

• 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

  43 days

• Blood drug concentration of Lotilaner at Day 43

  43 days

Study Arms (2)

Lotilaner Ophthalmic Solution (TP-03)

EXPERIMENTAL

Lotilaner Ophthalmic Solution (TP-03)

Drug: Lotilaner

Vehicle Control

PLACEBO COMPARATOR

Vehicle Control

Drug: Vehicle Control

Interventions

Lotilaner DRUG

Lotilaner Ophthalmic Solution

Also known as: TP-03, S-Misoxam

Lotilaner Ophthalmic Solution (TP-03)

Vehicle Control DRUG

Vehicle of TP-03 ophthalmic solution

Vehicle Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 years of age.
• Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
• Has blepharitis
• Stated willingness to comply with all study procedures and availability for the duration of the study.

You may not qualify if:

• 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.
• 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
• Pregnancy or lactation.
• 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
• 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.

Sponsors & Collaborators

• LianBio LLC: lead

Study Sites (21)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100005, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Chongqing Aier Eye Hospital

Chongqing, Chongqing Municipality, 400020, China

Location

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, 361000, China

Location

Guangzhou Aier Eye Hospital

Guangzhou, Guangdong, 510040, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Hainan Eye Hospital

Haikou, Hainan, 570311, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150007, China

Location

Henan Provincial Eye Hospital

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410007, China

Location

Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

Location

Wuxi Second People's Hospital

Wuxi, Jiangsu, 214002, China

Location

Eye& Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200940, China

Location

Shanxi Provincial Eye Hospital

Taiyuan, Shanxi, 030002, China

Location

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300392, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Blepharitis

Interventions

lotilaner

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Zuguo Liu, M.D

  Xiamen Eye Center of Xiamen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: October 23, 2022
• Primary Completion: September 15, 2023
• Study Completion: April 2, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (21)