Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Phase: PHASE2
Conditions: Blepharitis
Sponsor: Tarsus Pharmaceuticals, Inc.

Randomized, Controlled, Multicenter, Double-Masked, 
Parallel, Phase 2b/3 Trial to Evaluate the Safety and 
Efficacy of TP-03 for the Treatment of Demodex 
Blepharitis (Saturn-1)  
Protocol Number: TRS-009 
IND Sponsor: Tarsus Pharmaceuticals, Inc. 
Funded by: Tarsus Pharmaceuticals, Inc. 
 
25-Jan-2021
            NCT04475432

Saturn-1 Trial 
 
Protocol TRS-009 
 
  
 
1 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312)  
 
Investigators and clinical trial site staff who are responsible for the conduct, management, or oversight 
of clinical trials have completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the 
protocol and the consent form must be obtained before any participant is enrolled.  Any amendment to 
the protocol will require review and approval by the IRB before the changes are implemented to the 
study.  In addition, all changes to the consent form will be IRB-approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided consent using a 
previously approved consent form. 
 
1 
 
PROTOCOL SUMMARY 
  
1.1 
SYNOPSIS  
Title: 
Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 
2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment 
of Demodex Blepharitis (Saturn-1) 
  
Study Description and 
Hypotheses: 
This Phase 2b/3 study is a randomized, controlled, multicenter, double-
masked, parallel trial to compare the safety and efficacy of TP-03 to 
vehicle control for the treatment of Demodex blepharitis.  The 
hypothesis for the study is the proportion of participants cured at Day 43 
with treatment by TP-03, lotilaner ophthalmic solution, 0.25%, is greater 
than the proportion cured by treatment with vehicle.    
  
Test Article: 
TP-03, lotilaner ophthalmic solution, 0.25% 
 
Control Article: 
Vehicle of TP-03 
 
Study Design: 
Prospective, randomized, double-masked, multicenter, two-arm, parallel 
vehicle-controlled study 
 
Objective: 
To demonstrate the safety and efficacy of TP-03, 0.25%, for the 
treatment of Demodex blepharitis 
 
Endpoints: 
Primary Endpoint:  Proportion of participants cured based on their 
collarette score of the upper eyelid of the analysis eye at Day 43. 

Saturn-1 Trial 
 
Protocol TRS-009 
 
  
 
2 
 
Secondary Endpoints:   
• 
Proportion of participants with their Demodex mites eradicated in 
the analysis eye at Day 43. 
• 
Proportion of participants cured based on a composite of collarette 
and erythema scores of the upper eyelid of the analysis eye at Day 
43. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Safety will be determined by assessing adverse effects related to the 
active treatment as well as evaluating any changes in visual acuity, 
intraocular pressure, slit lamp biomicroscopy and dilated 
ophthalmoscopy findings.  
 
 
 
 
Phase: 
2b/3 
 
Number of Participants: 
 
Up to 418 participants 
 
 
 
Study Population: 
Participants with blepharitis due to Demodex infestation defined as 
having an elevated mite density, collarettes and erythema 
 
Description of Sites: 
 
   
Description of Study 
Treatment: 
Participants eligible to be randomized will receive one of the following 
treatments administered bilaterally BID for 43 days:  TP-03, 0.25%, or 
the TP-03 vehicle ophthalmic solution.   
  
Study Duration: 
 
 
Participant Duration: 
The study duration for an individual participant is estimated to be 
approximately  weeks for participants enrolled in 
 and 
 
weeks for participants enrolled in