Phase 3
Completed N=412
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Source: ClinicalTrials.gov NCT04784091 ↗Enrolled (actual)
412
Serious AEs
1.7%
Results posted
Dec 2023
Primary outcomePrimary: The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid. — 0.547; 0.122 Proportion cured
◆ Published Evidence
Established
45citations · ~15 / year
Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2).
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.
Linked Publications
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Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Participants Cured Based on Their Collarette Score of 0 for the Upper Eyelid. |
0.547; 0.122 | — |
| SECONDARY The Proportion of Participants With Their Demodex Mites Eradicated. |
0.499; 0.14 | — |
| SECONDARY The Proportion of Participants Cured Based on a Composite of Collarette Score and Erythema Score |
0.187; 0.039 | — |
| SECONDARY The Proportion of Participants Cured Based on Erythema Score. |
0.303; 0.091 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04784091) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.