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TP-03 for Blepharitis (Saturn-2 Trial)

Phase 3
Waitlist Available
Led By John Meyer, 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 43 days
Awards & highlights

Summary

This trial tests TP-03 eyedrops on adults with Demodex blepharitis, an eye condition caused by tiny mites. The drops aim to kill these mites, reducing irritation and inflammation. Previous studies have shown that the solution is effective and safe in treating this condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 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
The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.
Secondary outcome measures
The Proportion of Participants Cured Based on Erythema Score.
The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score
The Proportion of Participants With Their Demodex Mites Eradicated.

Side effects data

From 2022 Phase 3 trial • 412 Patients • NCT04784091
8%
Instillation site pain
2%
Dry eye
2%
Punctate keratitis
2%
Hordeolum
2%
Visual acuity reduced
1%
Seasonal allergy
1%
Conjunctival haemorrhage
1%
Conjunctival hyperaemia
1%
Eyelid oedema
1%
Nasopharyngitis
1%
Urinary tract infection
1%
SARS-CoV-2 test positive
1%
Chalazion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active
Control

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Group II: ControlPlacebo Group1 Intervention
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TP-03
2021
Completed Phase 3
~460

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Who is running the clinical trial?

Tarsus Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
863 Total Patients Enrolled
4 Trials studying Blepharitis
663 Patients Enrolled for Blepharitis
John Meyer, MDPrincipal InvestigatorThe Eye Care Institute
~95 spots leftby Sep 2025
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