NCT05629390Phase 3Completed

Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-15Actual

Enrollment · participants163Actual

Source updated2024-05-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Blepharitis

Treatments or interventions studied

LotilanerDrugAlso known as TP-03, S-Misoxam
Vehicle ControlDrug

Primary outcomes · main study measures

Read the study measures

measure: The proportion of participants cured based on their collarette score of 0 for the upper eyelid of the analysis eye.; description: To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis; timeFrame: 43 days; measure: The proportion of participants with Demodex eradication based on the mite density of 0 mites/lash for the analysis eye at Day 43; description: To demonstrate the efficacy of 0.25% Lotilaner Ophthalmic Solution to eliminate collarettes and eradicate mite in Demodex blepharitis; timeFrame: 43 days; measure: The assessment of treatment-related adverse effects; description: To demonstrate the safety of 0.25% TP-03 in Demodex blepharitis; timeFrame: 43 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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