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

Primary Purpose

Blepharitis

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lotilaner
Vehicle Control
Sponsored by
LianBio LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Blepharitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Beijing Tongren Hospital
  • Peking University Third Hospital
  • Chongqing Aier Eye Hospital
  • Xiamen Eye Center of Xiamen University
  • Guangzhou Aier Eye Hospital
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Hainan Eye Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • Henan Provincial Eye Hospital
  • Union Hospital, Tongji Medical College Huazhong University of Science and Technology
  • Renmin Hospital of Wuhan University
  • The Second Xiangya Hospital of Central South University
  • Xiangya Hospital, Central South University
  • The First Affiliated Hospital of University of South China
  • Wuxi Second People's Hospital
  • Eye& Ent Hospital of Fudan University
  • Shanghai General Hospital
  • Shanxi Provincial Eye Hospital
  • Tianjin Medical University Eye Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Eye Hospital, Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lotilaner Ophthalmic Solution (TP-03)

Vehicle Control

Arm Description

Lotilaner Ophthalmic Solution (TP-03)

Vehicle Control

Outcomes

Primary Outcome Measures

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
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
The assessment of treatment-related adverse effects
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis

Secondary Outcome Measures

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
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

Full Information

First Posted
November 17, 2022
Last Updated
October 22, 2023
Sponsor
LianBio LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05629390
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LianBio LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
Keywords
Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lotilaner Ophthalmic Solution (TP-03)
Arm Type
Experimental
Arm Description
Lotilaner Ophthalmic Solution (TP-03)
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Vehicle Control
Intervention Type
Drug
Intervention Name(s)
Lotilaner
Other Intervention Name(s)
TP-03, S-Misoxam
Intervention Description
Lotilaner Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Vehicle Control
Intervention Description
Vehicle of TP-03 ophthalmic solution
Primary Outcome Measure Information:
Title
The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.
Description
To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis
Time Frame
43 days
Title
The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43
Description
To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis
Time Frame
43 days
Title
The assessment of treatment-related adverse effects
Description
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
Time Frame
43 days
Secondary Outcome Measure Information:
Title
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
Description
To demonstrate the efficacy of TP-03 to eliminate collarettes and erythema from the eyelid margin
Time Frame
43 days
Title
Blood drug concentration of Lotilaner at Day 43
Description
To evaluate the blood drug concentration of Lotilaner following topical ocular administration of TP-03administration of 0.25% TP-03
Time Frame
43 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuguo Liu, M.D
Organizational Affiliation
Xiamen Eye Center of Xiamen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Chongqing Aier Eye Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400020
Country
China
Facility Name
Xiamen Eye Center of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Facility Name
Guangzhou Aier Eye Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510040
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Hainan Eye Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150007
Country
China
Facility Name
Henan Provincial Eye Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Wuxi Second People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Name
Eye& Ent Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200940
Country
China
Facility Name
Shanxi Provincial Eye Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030002
Country
China
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300392
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Eye Hospital, Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

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

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