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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Lotilaner Ophthalmic Solution
Vehicle of TP-03 ophthalmic solution
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
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
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing Aier Eye Hospital
Chongqing, Chongqing Municipality, 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
...and 11 more locations