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Completed

NCT Number: NCT04784091

Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

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.

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Retina Institute, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TP-03

Drug

TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day

TP-03 Vehicle

Drug

Vehicle of TP-03 ophthalmic solution, administered twice a day

Primary outcomes

  1. The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid.

    Time frame: 43 days

    The proportion of subjects cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye.

    The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values

Secondary outcomes

  1. The Proportion of Participants With Their Demodex Mites Eradicated.

    Time frame: 43 days

    The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes.

    The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values

  2. The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score

    Time frame: 43 days

    The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43.

    The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.

  3. The Proportion of Participants Cured Based on Erythema Score.

    Time frame: 43 days

    The proportion of participants cured based on erythema where cure is defined as having a normal eyelid erythema of the analysis eye at day 43.

    The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.

Sponsors and collaborators

Lead sponsor

Tarsus Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: Saturn-2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 5, 2021
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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