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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05201170 | A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye | PHASE3 | COMPLETED | 575 | — | — | Dec 30, 2021 | Nov 21, 2023 | Oct 17, 2024 | 18 | United States |
Measured by the Ora Calibra® Scale. Change from Baseline to week 12.
As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.
| Arm | Type | Description |
|---|---|---|
| PL9643 Ophthalmic Solution | EXPERIMENTAL | PL9643 ophthalmic solution bilaterally three times a day. |
| Vehicle Ophthalmic Solution | ACTIVE_COMPARATOR | Vehicle ophthalmic solution bilaterally three times a day. |
| Name | Type | Description |
|---|---|---|
| Vehicle Ophthalmic Solution | DRUG | Ophthalmic Solution |
| PL9643 Ophthalmic Solution | DRUG | Ophthalmic Solution |
Inclusion Criteria: 1. Be at least 18 years of age; 2. Provide written informed consent; 3. Be willing and able to comply with all study procedures; 4. Have a patient-reported history of dry eye for at least 5 years prior to Visit 1; 5. Have a history of use or desire to use eye drops for dry eye s...