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Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-2)

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ClinicalTrials.gov Identifier: NCT04784091
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
Tarsus Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: TP-03 Drug: TP-03 Vehicle Phase 3

Detailed Description:
This Phase 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 primary objective of the study is to assess the safety and efficacy of TP-03, 0.25% compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy, endothelial cell density, hematology, blood chemistry, and urinalysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active arm: TP-03, 0.25% Control arm: Vehicle of TP-03
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment assignment will be unknown to the study participant, investigators and site staff performing study assessments.
Primary Purpose: Treatment
Official Title: Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: Active
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Drug: TP-03
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day

Placebo Comparator: Control
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
Drug: TP-03 Vehicle
Vehicle of TP-03 ophthalmic solution, administered twice a day




Primary Outcome Measures :
  1. The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]

Secondary Outcome Measures :
  1. The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]
  2. The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 43 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
  • Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion Criteria:

  • Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
  • Have used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment during the study
  • Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
  • Be pregnant or lactating at the time of Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784091


Contacts
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Contact: Yesha Raval 978-685-8900 ext 9423 yraval@oraclinical.com
Contact: Jordan Janeiro 978-685-8900 ext 9436 jjaneiro@oraclinical.com

Locations
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United States, Colorado
Vision Institute Not yet recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Helene Agbo    719-559-2020    helene@vicolorado.com   
United States, Florida
Pinnacle Research Institute Recruiting
Fort Lauderdale, Florida, United States, 33309
Contact: Valentine Jean-Baptiste    954-597-6445    valentine@priclinical.com   
United States, Indiana
Michael Washburn Center for Ophthalmic Research LLC Not yet recruiting
Indianapolis, Indiana, United States, 46113
Contact: Jessica Gill    317-231-2331    jgill@whitsonvision.com   
United States, Kentucky
The Eye Care Institute Recruiting
Louisville, Kentucky, United States, 40206
Contact: Kellye Johnson    502-589-1500    kjohnson@eyecareinstitute.com   
United States, Missouri
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Dawn Wiemers    314-966-3377    dawnwiemers@eyecare-partners.com   
United States, North Carolina
Vita Eye Clinic Recruiting
Shelby, North Carolina, United States, 28150
Contact: Winnie Simmons    704-487-4099    wsimmons@oraclinical.com   
United States, Utah
Alpine Research Organization / Healthy Heart Clinics of America Not yet recruiting
Layton, Utah, United States, 84041
Contact: Amy Kenley    385-381-2652    amyk@alpine-research.com   
United States, West Virginia
New River Vision Care Not yet recruiting
Oak Hill, West Virginia, United States, 25901
Contact: Vivian Donelow    304-465-0269    newrivervisioncare@gmail.com   
Sponsors and Collaborators
Tarsus Pharmaceuticals, Inc.
Investigators
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Principal Investigator: John Meyer, MD The Eye Care Institute
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Responsible Party: Tarsus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04784091    
Other Study ID Numbers: TRS-010
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tarsus Pharmaceuticals, Inc.:
Demodex
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases