Trial Outcomes & Findings for Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (NCT NCT04475432)

Last Updated: 2023-12-21

Results Overview

The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

421 participants

Primary outcome timeframe

43 days

Results posted on

2023-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Active TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day	Control Vehicle of TP-03 topical ophthalmic solution, administered twice a day
Overall Study STARTED	212	209
Overall Study COMPLETED	208	203
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=212 Participants TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day	Control n=209 Participants Vehicle of TP-03 topical ophthalmic solution, administered twice a day	Total n=421 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=5 Participants	65 Participants n=7 Participants	151 Participants n=5 Participants
Age, Categorical >=65 years	126 Participants n=5 Participants	144 Participants n=7 Participants	270 Participants n=5 Participants
Age, Continuous	66.1 years STANDARD_DEVIATION 12.09 • n=5 Participants	67.8 years STANDARD_DEVIATION 12.63 • n=7 Participants	67.0 years STANDARD_DEVIATION 12.37 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	117 Participants n=7 Participants	240 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	92 Participants n=7 Participants	181 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	198 Participants n=5 Participants	198 Participants n=7 Participants	396 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	195 Participants n=5 Participants	187 Participants n=7 Participants	382 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	212 participants n=5 Participants	209 participants n=7 Participants	421 participants n=5 Participants

PRIMARY outcome

Timeframe: 43 days

Outcome measures

Outcome measures
Measure	Active n=212 Participants TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day	Control n=209 Participants Vehicle of TP-03 topical ophthalmic solution, administered twice a day
Proportion of Participants Cured Based on a Collarette Score at Day 43.	0.439 Proportion cured Standard Error 0.034	0.072 Proportion cured Standard Error 0.018

SECONDARY outcome

Timeframe: 43 days

The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values

Outcome measures

Outcome measures
Measure	Active n=212 Participants TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day	Control n=209 Participants Vehicle of TP-03 topical ophthalmic solution, administered twice a day
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43	0.677 Proportion eradicated Standard Error 0.032	0.173 Proportion eradicated Standard Error 0.026

SECONDARY outcome

Timeframe: 43 days

The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.

Outcome measures

Outcome measures
Measure	Active n=212 Participants TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day	Control n=209 Participants Vehicle of TP-03 topical ophthalmic solution, administered twice a day
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.	0.139 Proportion cured Standard Error 0.024	0.01 Proportion cured Standard Error 0.007

Adverse Events

Active

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=212 participants at risk TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day for approximately 43 days	Control n=209 participants at risk Vehicle of TP-03 topical ophthalmic solution, administered twice a day for approximately 43 days
Infections and infestations COVID-19	0.47% 1/212 • 57 days Corresponds to the standard definition.	0.00% 0/209 • 57 days Corresponds to the standard definition.
Infections and infestations Pneumonia	0.47% 1/212 • 57 days Corresponds to the standard definition.	0.00% 0/209 • 57 days Corresponds to the standard definition.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	0.00% 0/212 • 57 days Corresponds to the standard definition.	0.48% 1/209 • 57 days Corresponds to the standard definition.
Renal and urinary disorders Haematuria	0.47% 1/212 • 57 days Corresponds to the standard definition.	0.00% 0/209 • 57 days Corresponds to the standard definition.

Other adverse events

Other adverse events
Measure	Active n=212 participants at risk TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day for approximately 43 days	Control n=209 participants at risk Vehicle of TP-03 topical ophthalmic solution, administered twice a day for approximately 43 days
Eye disorders Visual acuity reduced	2.8% 6/212 • 57 days Corresponds to the standard definition.	2.9% 6/209 • 57 days Corresponds to the standard definition.
Eye disorders Eye pain	1.4% 3/212 • 57 days Corresponds to the standard definition.	1.4% 3/209 • 57 days Corresponds to the standard definition.
Eye disorders Eye discharge	1.4% 3/212 • 57 days Corresponds to the standard definition.	0.96% 2/209 • 57 days Corresponds to the standard definition.
Eye disorders Chalazion	0.47% 1/212 • 57 days Corresponds to the standard definition.	1.4% 3/209 • 57 days Corresponds to the standard definition.
Eye disorders Vision blurred	0.94% 2/212 • 57 days Corresponds to the standard definition.	0.96% 2/209 • 57 days Corresponds to the standard definition.
Eye disorders Eye pruritus	0.47% 1/212 • 57 days Corresponds to the standard definition.	0.96% 2/209 • 57 days Corresponds to the standard definition.
Eye disorders Swelling of eyelid	0.47% 1/212 • 57 days Corresponds to the standard definition.	0.96% 2/209 • 57 days Corresponds to the standard definition.
General disorders Instillation site pain	11.8% 25/212 • 57 days Corresponds to the standard definition.	7.7% 16/209 • 57 days Corresponds to the standard definition.
General disorders Instillation site pruritus	1.4% 3/212 • 57 days Corresponds to the standard definition.	3.3% 7/209 • 57 days Corresponds to the standard definition.

Additional Information

Mark Holdbrook, Senior Vice-President of Clinical Development

Tarsus Pharmaceuticals, Inc.

Phone: 408-431-6613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee It is specified in the protocol that the data generated in this clinical trial, all related information and any materials containing such data and information are the exclusive property of Tarsus Pharmaceuticals, Inc. and are confidential to Tarsus Pharmaceuticals. Also, the investigator or other study-related personnel may not disclose to anyone or use any data, information or materials related to this clinical trial without the express written consent of Tarsus Pharmaceuticals.
Publication restrictions are in place

Restriction type: OTHER