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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04362670 | Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease. | PHASE1 | COMPLETED | 153 | — | — | Apr 23, 2020 | Aug 11, 2021 | Nov 14, 2023 | 15 | United States |
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
| Arm | Type | Description |
|---|---|---|
| OTX-CSI-Cohort 1 | EXPERIMENTAL | Formulation 2A-.36 mg |
| OTX-CSI-Cohort 2 | EXPERIMENTAL | Formulation 1- .36 mg |
| HV | PLACEBO_COMPARATOR | Cohort 2: Formulation 2B |
| OTX-CSI- Cohort 2 | EXPERIMENTAL | Formulation 2A- .36 mg |
| HV-2 | PLACEBO_COMPARATOR | Cohort 2: Formulation 3 |
| Name | Type | Description |
|---|---|---|
| OTX-CSI | DRUG | OTX-CSI intracanalicular insert |
| Placebo Vehicle | OTHER | Hydrogel Vehicle intracanalicular insert |
Inclusion Criteria: * Dry eye disease diagnosis * VAS eye dryness severity score ≥ 30. Exclusion Criteria: * Are unwilling to discontinue use of contact lenses * Are unwilling to withhold use of artificial tears.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD, ABBV-319 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | GRF312 5% |
| Bausch + Lomb Corporation | BLCO | 1 | PHASE2 | Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Perfluorohexyloctane, Vehicle |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 2 | NA | Undisclosed |
| Harrow, Inc. | HROW | 1 | — | Undisclosed |