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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04268069 | Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye | PHASE2 | COMPLETED | 160 | — | — | Feb 14, 2020 | Oct 5, 2020 | Nov 13, 2020 | 4 | United States |
An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
A patient-reported subjective assessment of ocular discomfort using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale recorded at each study visit throughout the treatment period
| Arm | Type | Description |
|---|---|---|
| Placebo Ophthalmic Solution (vehicle) | PLACEBO_COMPARATOR | vehicle |
| PL9643 Ophthalmic Solution | ACTIVE_COMPARATOR | PL9643 Ophthalmic Solution |
| Name | Type | Description |
|---|---|---|
| PL9643 Ophthalmic Solution | DRUG | PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
| Placebo Ophthalmic Solution | DRUG | Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
Inclusion Criteria: * Be at least 18 years of age. * Provided written informed consent. * Have a reported history of dry eye * Have a history of use or desire to use eye drops for dry eye symptoms * Have corrected visual acuity greater than or equal to +0.7 in both eyes Exclusion Criteria: * Be d...
| 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 |