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Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD (Ersa Trial)
Phase 2
Waitlist Available
Led By Mitchell Shultz, MD
Research Sponsored by Tarsus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights
No Placebo-Only Group
Summary
This trialtests a new eye drop to help people with Demodex lid infestation, comparing its safety and effectiveness when used twice daily vs three times daily.
Eligible Conditions
- Meibomian Gland Dysfunction
- Blepharitis
- Demodex Mite Infestation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 85 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment Emergent Adverse Events (TEAEs)
Other study objectives
Erythema
Change from baseline in lower lid meibomian gland secretion score.
Change from baseline in ocular surface staining assessed via slit lamp.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TID DosingExperimental Treatment1 Intervention
TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days
Group II: BID DosingExperimental Treatment2 Interventions
TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-03
2021
Completed Phase 3
~460
TP-03 Vehicle
2021
Completed Phase 3
~880
Find a Location
Who is running the clinical trial?
Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,235 Total Patients Enrolled
1 Trials studying Meibomian Gland Dysfunction
36 Patients Enrolled for Meibomian Gland Dysfunction
Mitchell Shultz, MDPrincipal InvestigatorMitchell C. Shultz, MD