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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05378945 | Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease | PHASE3 | COMPLETED | 340 | — | — | Jul 22, 2022 | Apr 4, 2023 | Apr 25, 2023 | 20 | China |
| NCT05576415 | Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye Disease | PHASE1 | COMPLETED | 9 | — | — | Dec 7, 2022 | Apr 27, 2023 | May 1, 2023 | 1 | China |
Percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline
To evaluate the Cmax of varenicline in adult Chinese with dry eye disease (DED) after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the Tmax of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the AUCtau of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the AUC0-last of varenicline in adult Chinese subjects with DED after the first dosing at Visit 1 \[Day 1\] and after the last dosing at Visit 3 \[Day 28\], respectively.
To evaluate the T1/2 of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.
To evaluate the λz of varenicline after the last dosing at Visit 3 \[Day 28\] in adult Chinese subjects with DED.
| Arm | Type | Description |
|---|---|---|
| OC-01 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Varenicline Tartrate Nasal Spray | DRUG | Intranasal delivery of OC-01 (varenicline solution) 0.6 mg/mL twice a day (BID) for 28 days |
| Placebo (vehicle) | DRUG | Intranasal delivery of placebo (vehicle) twice a day (BID) for 28 days |
Inclusion Criteria: * Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit Exclusion Criteria: * Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in either eye within three months or refra...
| 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 |