BlepharitisPhase 3NCT05629390
Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study
A Phase 3 study testing Lotilaner in people with Blepharitis, run by LianBio LLC at 21 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Blepharitis
- What is being tested?
- Lotilaner
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 21 sitesChina
- Study dates
- 23 Oct 2022to 2 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100005
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410007
Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Chongqing Aier Eye Hospital
Chongqing, Chongqing Municipality, 400020
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, 510040
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Hainan Eye Hospital
Haikou, Hainan, 570311
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150007
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Eye& Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200940
Shanxi Provincial Eye Hospital
Taiyuan, Shanxi, 030002
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300392
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Wuxi Second People's Hospital
Wuxi, Jiangsu, 214002
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, 361000
Henan Provincial Eye Hospital
Zhengzhou, Henan, 450008
About this 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
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
Read the 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.
- Conditions
- Blepharitis
- Being tested
- Lotilaner, Vehicle Control
- Keywords
- Blepharitis
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LotilanerDrug
Also called TP-03, S-Misoxam
Lotilaner Ophthalmic Solution
Vehicle ControlDrug
Vehicle of TP-03 ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Lotilaner Ophthalmic Solution (TP-03) | Experimental | Lotilaner Ophthalmic Solution (TP-03) Receives: Drug: Lotilaner |
| Vehicle Control | Placebo comparator | Vehicle Control Receives: Drug: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 43 days
The assessment of treatment-related adverse effects
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
Measured: 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
To demonstrate the efficacy of TP-03 to eliminate collarettes and erythema from the eyelid margin
Measured: 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
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start23 Oct 2022
- Primary completion15 Sep 2023
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- LianBio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zuguo Liu, M.D, Principal investigator, Xiamen Eye Center of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629390
- Sponsor's protocol ID
- LB4001-301
- Status last verified
- May 2024
- First submitted
- 17 Nov 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05629390
- Acronym / sponsor ID
- LB4001-301
- Conditions
- Blepharitis
- Keywords
- Blepharitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- LianBio LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lotilaner Ophthalmic Solution (TP-03) | Experimental | Drug: LotilanerLotilaner Ophthalmic Solution (TP-03) |
| Vehicle Control | Placebo comparator | Drug: Vehicle ControlVehicle Control |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LotilanerAlso: TP-03, S-MisoxamLotilaner Ophthalmic Solution | Drug | Lotilaner Ophthalmic Solution (TP-03) |
| Vehicle ControlVehicle of TP-03 ophthalmic solution | Drug | Vehicle Control |
Primary outcome
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
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
The assessment of treatment-related adverse effects
Time frame: 43 days
To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis
2 secondary outcomes
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
Blood drug concentration of Lotilaner at Day 43
Time frame: 43 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuguo Liu, M.D principal investigator
Xiamen Eye Center of Xiamen University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lotilaner in people with Blepharitis, run by LianBio LLC at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye. (time frame: 43 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.