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BID Dosing for Meibomian Gland Dysfunction (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

Ersa Trial 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
  • Demodex Mite Infestation
  • Blepharitis

Ersa Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Emergent Adverse Events (TEAEs)
Other outcome measures
Change from baseline in dry eye symptoms using a visual analog scale, scores ranging from 0 to 100, evaluating eye dryness, ocular discomfort, fluctuating vision, burning, itching, and redness for the one week period prior to the in-office visit.
Erythema
Change from baseline in lower lid meibomian gland secretion score.
+2 more

Ersa 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability for enrolment in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this research trial, which was first announced on August 3rd 2022, is presently recruiting volunteers. 40 participants are needed from four distinct locations."

Answered by AI

Could you elucidate to what degree TID Dosing poses a risk for patients?

"We have assigned TID Dosing a score of 2, since there is some data indicating its safety but no clinical evidence backing up its efficacy."

Answered by AI

What locations in Canada are conducting this medical research?

"This scientific research is being conducted at Silverstein Eye Center in Kansas City, Missouri, Medical Optometry America in New Freedom, Pennsylvania and Mitchell C. Shultz MD in Northridge, California as well as extra 4 sites."

Answered by AI

How many participants are currently enrolled in this trial?

"Tarsus Pharmaceuticals, Inc. will be spearheading this research project and requires 40 eligible participants to commence the study at two different locations - Silverstein Eye Center of Kansas City, Missouri and Medical Optometry America in New Freedom, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
Silverstein Eye Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm a healthy volunteer.
PatientReceived 1 prior treatment
~15 spots leftby Mar 2025