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NCT Number: NCT05629390

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

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tongren Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lotilaner

Drug

Lotilaner Ophthalmic Solution

Other names: TP-03, S-Misoxam

vehicle control

Drug

Vehicle of TP-03 ophthalmic solution

Primary outcomes

  1. The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.

    Time frame: 43 days

    To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis

  2. The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43

    Time frame: 43 days

    To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis

  3. The assessment of treatment-related adverse effects

    Time frame: 43 days

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

Secondary outcomes

  1. 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

    Time frame: 43 days

    To demonstrate the efficacy of TP-03 to eliminate collarettes and erythema from the eyelid margin

  2. Blood drug concentration of Lotilaner at Day 43

    Time frame: 43 days

    To evaluate the blood drug concentration of Lotilaner following topical ocular administration of TP-03administration of 0.25% TP-03

Sponsors and collaborators

Lead sponsor

LianBio LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 29, 2022
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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