Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05454956 | Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD | PHASE2 | COMPLETED | 39 | — | — | Aug 3, 2022 | May 18, 2023 | Oct 1, 2025 | 5 | United States |
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
| Arm | Type | Description |
|---|---|---|
| BID Dosing | EXPERIMENTAL | TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day to maintain masking for approximately 85 days |
| TID Dosing | EXPERIMENTAL | TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day for approximately 85 days |
| Name | Type | Description |
|---|---|---|
| TP-03 | DRUG | TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm |
| TP-03 Vehicle | DRUG | Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms |
Inclusion Criteria: * Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more m...