Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
- Registration Number
- NCT05629390
- Lead Sponsor
- LianBio LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Control Vehicle Control Vehicle Control Lotilaner Ophthalmic Solution (TP-03) Lotilaner Lotilaner Ophthalmic Solution (TP-03)
- Primary Outcome Measures
Name Time Method The assessment of treatment-related adverse effects 43 days To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye. 43 days 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 43 days To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis
- Secondary Outcome Measures
Name Time Method 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 To demonstrate the efficacy of TP-03 to eliminate collarettes and erythema from the eyelid margin
Blood drug concentration of Lotilaner at Day 43 43 days To evaluate the blood drug concentration of Lotilaner following topical ocular administration of TP-03administration of 0.25% TP-03
Trial Locations
- Locations (21)
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Chongqing Aier Eye Hospital
🇨🇳Chongqing, Chongqing, 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
Scroll for more (11 remaining)Beijing Tongren Hospital🇨🇳Beijing, Beijing, China