Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Cmax at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tmax at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Tlag at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-168 at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-2880 at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-t at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC0-inf at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner CL/F at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Vz/F at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner eff at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Thalf at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner ?z at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner AUC%extrap at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner MRT0-t at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Rac at various times |
42 Days |
|
Primary |
To evaluate the concentration of lotilaner in blood multiple doses of TP-03, 0.25% in whole blood following topical ocular administration in healthy adult subjects for 42 days. |
The primary PK endpoints following single and multiple dose administration will include whole blood PK parameters for lotilaner Ctrough at various times |
42 Days |
|
Primary |
Incidence of treatment emergent adverse events (TEAEs) |
Safety will be evaluated through the incidence rate of TEAEs |
42 Days |
|
Primary |
Clinically significant changes from Baseline chemistry laboratory tests |
Evaluate the safety of TP-03 through clinically significant changes from Baseline chemistry laboratory tests |
42 Days |
|
Primary |
Clinically significant changes from Baseline hematology laboratory tests |
Evaluate the safety of TP-03 through clinically significant changes from Baseline hematology laboratory tests |
42 Days |
|
Primary |
Clinically significant changes from Baseline physical examinations |
Safety will be evaluated through review of clinically significant changes in physical examinations from Baseline |
42 Days |
|
Primary |
Clinically significant changes from Baseline electrocardiograms (ECGs) |
Safety will be evaluated through review of clinically significant changes in electrocardiograms from Baseline |
42 Days |
|
Primary |
Clinically significant changes from Baseline vitals |
Safety will be evaluated through review of clinically significant changes from Baseline vital signs (including temperature [degrees Celsius], pulse rate [beats per minute], respiration rate [breaths per minute], and changes in systolic and diastolic blood pressure [mmHg]) from Baseline |
42 Days |
|
Primary |
Clinically significant changes from Baseline corrected distance visual acuity |
Safety will be evaluated through review of clinically significant changes in corrected distance visual acuity from Baseline |
42 Days |
|
Primary |
Clinically significant changes from Baseline non-mydriatic fundus photographs |
Safety will be evaluated through review of clinically significant changes in non-mydriatic fundus photographs from Baseline |
42 Days |
|
Primary |
Clinically significant changes from Baseline intraocular pressure (IOP) measurement |
Safety will be evaluated through review of clinically significant changes in IOP from Baseline |
42 Days |
|