Trial Outcomes & Findings for Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD (NCT NCT05454956)
NCT ID: NCT05454956
Last Updated: 2025-10-01
Results Overview
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
85 days
Results posted on
2025-10-01
Participant Flow
The protocol stated up to 40 subjects to be enrolled. A total of 39 subjects were enrolled in the study which adhered to the protocol.
Participant milestones
| Measure |
BID Dosing
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
18
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD
Baseline characteristics by cohort
| Measure |
BID Dosing
n=21 Participants
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 Participants
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 15.74 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 13.13 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 14.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 85 daysNumber of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Outcome measures
| Measure |
BID Dosing
n=21 Participants
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 Participants
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 85 visitPopulation: The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol
For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45
Outcome measures
| Measure |
BID Dosing
n=20 analysis eye
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 analysis eye
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85
|
10.5 score on a scale
Standard Deviation 6.94
|
11.7 score on a scale
Standard Deviation 7.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 85 visitPopulation: The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol
Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe).
Outcome measures
| Measure |
BID Dosing
n=20 analysis eye
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 analysis eye
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85
|
-1.1 score on a scale
Standard Deviation 0.85
|
-1.0 score on a scale
Standard Deviation 0.59
|
Adverse Events
BID Dosing
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
TID Dosing
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BID Dosing
n=21 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Nervous system disorders
Presyncope
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
Other adverse events
| Measure |
BID Dosing
n=21 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day
|
TID Dosing
n=18 participants at risk
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day
|
|---|---|---|
|
Infections and infestations
Conjunctivitis
|
4.8%
1/21 • 200 days
|
5.6%
1/18 • 200 days
|
|
Eye disorders
Ocular discomfort
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Eye disorders
Conjunctivochalasis
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Eye disorders
Vitreous floaters
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Infections and infestations
Bronchitis
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Infections and infestations
COVID-19
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Infections and infestations
Gastroenteritis viral
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Infections and infestations
Hordeolum
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21 • Number of events 3 • 200 days
|
0.00%
0/18 • 200 days
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • 200 days
|
0.00%
0/18 • 200 days
|
Additional Information
Kavita Dhamdhere, Vice President of Clinical Development
Tarsus Pharmaceuticals, Inc.
Phone: 650-223-4062
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