Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis (Saturn-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04475432 |
Recruitment Status :
Completed
First Posted : July 17, 2020
Last Update Posted : July 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blepharitis | Drug: TP-03, 0.25% Drug: TP-03 Vehicle | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 421 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 2b/3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis |
Actual Study Start Date : | September 9, 2020 |
Actual Primary Completion Date : | May 4, 2021 |
Actual Study Completion Date : | May 4, 2021 |

Arm | Intervention/treatment |
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Experimental: Active
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
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Drug: TP-03, 0.25%
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
Other Name: Lotilaner ophthalmic solution, 0.25% |
Placebo Comparator: Control
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
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Drug: TP-03 Vehicle
Vehicle of TP-03 ophthalmic solution, administered twice a day |
- The proportion of participants cured based on their collarette score [ Time Frame: 43 days ]Cure is defined as the presence of no more than 2 collarettes on the upper eyelid
- The proportion of participants with their Demodex mites eradicated [ Time Frame: 43 days ]Mite eradication is defined as a mite density of 0 mites per lash
- The proportion of participants cured based on a composite of collarette score and erythema cure [ Time Frame: 43 days ]Cure is defined as the presence of no more than 2 collarettes and the absence of erythema (age normal) of the upper eyelid

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear 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
- Pregnancy or lactation

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): NCT04475432
United States, Arizona | |
Cornea and Cataract Consultants of Arizona | |
Phoenix, Arizona, United States, 85032 | |
United States, California | |
Eye Research Foundation | |
Newport Beach, California, United States, 92663 | |
Visionary Eye Institute | |
Newport Beach, California, United States, 92663 | |
United States, Colorado | |
Vision Institute | |
Colorado Springs, Colorado, United States, 80907 | |
United States, Indiana | |
Midwest Cornea Associates, LLC | |
Carmel, Indiana, United States, 46290 | |
Washburn Research LLC | |
Indianapolis, Indiana, United States, 46240 | |
United States, Kentucky | |
The Eye Care Institute | |
Louisville, Kentucky, United States, 40206 | |
United States, Massachusetts | |
Andover Eye Associates | |
Andover, Massachusetts, United States, 01810 | |
United States, Missouri | |
Ophthalmology Associates | |
Saint Louis, Missouri, United States, 63131 | |
United States, North Carolina | |
Oculus Research, Inc at EyecareCenter | |
Raleigh, North Carolina, United States, 27603 | |
Vita Eye Clinic | |
Shelby, North Carolina, United States, 28150 | |
United States, Pennsylvania | |
Scott & Christie and Associates, PC | |
Cranberry Township, Pennsylvania, United States, 16066 | |
United States, Tennessee | |
Total Eye Care, P.A. | |
Memphis, Tennessee, United States, 38119 | |
United States, Utah | |
Alpine Research Organization | |
Layton, Utah, United States, 84041 | |
United States, Virginia | |
Piedmont Eye Center | |
Lynchburg, Virginia, United States, 24502 |
Principal Investigator: | David Wirta, MD | Eye Research Foundation |
Responsible Party: | Tarsus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT04475432 |
Other Study ID Numbers: |
TRS-009 |
First Posted: | July 17, 2020 Key Record Dates |
Last Update Posted: | July 11, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Demodex |
Blepharitis Eyelid Diseases Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |