A Phase 3 interventional study of Lotilaner and Vehicle Control in Blepharitis, sponsored by LianBio LLC. Completed at 21 sites in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by LianBio LLC · Phase 3, Interventional, and Treatment
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
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 163 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →LianBio LLC is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lotilaner Ophthalmic Solution (TP-03)
Drug: Lotilaner
Vehicle Control
Drug: Vehicle Control
Lotilaner Ophthalmic Solution
Also known as: TP-03, S-Misoxam
Vehicle of TP-03 ophthalmic solution
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
Time frame: 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
Time frame: 43 days
The assessment of treatment-related adverse effects
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
Time frame: 43 days
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
Time frame: 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
Time frame: 43 days
Ran from Oct 2022 to primary completion in Sep 2023, 10 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lotilaner
LianBio LLC