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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05759208 | The Study Evaluating the Efficacy and Safety of OK-101 in Subjects With Dry Eye Disease | PHASE2 | COMPLETED | 240 | — | — | Apr 28, 2023 | Dec 15, 2023 | Feb 9, 2024 | 6 | United States |
Total corneal fluorescein staining score of the study eye using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each of the 5 areas will be scored on a scale of 0 to 4 for a total minimum score of 0 to total maximum score of 20, with 0 being best and 20 being worst.
Ocular discomfort score of both eyes using the Ora Calibra® scale, measured by mean change from baseline (Visit 2 pre-CAE®) to Day 85 (Visit 6). Each eye will be scored separately on a scale from 1 to 4, with 1 being best and 4 being worst.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | OK-101 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80) |
| Low Dose OK-101 | EXPERIMENTAL | 0.05% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) |
| High-Dose OK-101 | EXPERIMENTAL | 0.1% OK-101 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) |
| Name | Type | Description |
|---|---|---|
| OK-101 | DRUG | Ophthalmic Solution |
| Placebo | DRUG | Placebo |
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 6 months prior to Visit 1; 5. Have a history of use or desire to use eye drops for dry eye ...
| 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 |