At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 412 enrolled
Drug / intervention
TP-03 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Controlled, Multicenter, Double-Masked, Parallel, Phase 3 Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
In Brief
A Phase 3 clinical trial evaluating TP-03 and TP-03 Vehicle for Blepharitis. Completed, enrolled 412 participants across 21 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlepharitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartApr 2021
Primary CompletionMay 2022
TodayJul 2026
First PostedMar 5, 2021
Enrollment StartApr 29, 2021
Primary CompletionMay 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.3 years ago
Interventions
TP-03drug
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
TP-03 Vehicledrug
Vehicle of TP-03 ophthalmic solution, administered twice a day