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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05031806 | Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease | PHASE1 | COMPLETED | 30 | — | — | Sep 28, 2021 | Dec 1, 2021 | Mar 4, 2022 | 1 | United States |
Assessed using: Visual Acuity (VA) (ETDRS), Slit-lamp biomicroscopy, Adverse Event Query, Dilated Fundoscopy Interocular Pressure
Assessed using: Ora Calibra Drop Comfort Assessments
| Arm | Type | Description |
|---|---|---|
| iNexin™ (0.08% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| iNexin™ (0.4% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| iNexin™ (2.0% aCT1) | EXPERIMENTAL | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| Vehicle (eye drop formulation without aCT1) | PLACEBO_COMPARATOR | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
| Name | Type | Description |
|---|---|---|
| iNexin™ (0.08% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle.randomized 7:3 for each active concentration to Vehicle. |
| iNexin™ (0.4% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. |
| iNexin™ (2.0% aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. |
| Vehicle (eye drop formulation without aCT1) | DRUG | 36 eligible subjects will be randomized to Vehicle or one of three concentrations of iNexin™ to be administered bilaterally BID for 15 days (from Visit 2 to the evening of Visit 4). Subjects will be randomized 2:1 for each active concentration to Vehicle. During a 7-day study run-in period prior to randomization, all subjects will receive Vehicle eye drops (Vehicle) bilaterally BID (from Visit 1 to the evening before Visit 2). |
Inclusion Criteria: Subjects must meet all the following requirements to be eligible for enrollment into the study. 1. Be at least 18 years of age; 2. Provide written informed consent; 3. Have a self-reported history of dry eye for at least 6 months prior to Visit 1; 4. Have a history of use or de...
| 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 |