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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03489941 | A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle | PHASE3 | COMPLETED | 65 | — | — | Apr 7, 2018 | Apr 29, 2018 | Jun 8, 2023 | 1 | United States |
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
| Arm | Type | Description |
|---|---|---|
| EM-100 | EXPERIMENTAL | One drop of EM-100 in either the right or left eye once on Day 1. |
| Zaditor® | EXPERIMENTAL | One drop of Zaditor® in either the right or left eye once on Day 1. |
| Vehicle | EXPERIMENTAL | One drop of Vehicle in either the right or left eye once on Day 1. |
| Name | Type | Description |
|---|---|---|
| EM-100 | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
| Zaditor® | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
| Vehicle | DRUG | Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial. |
Inclusion Criteria: * be at least 18 years old * have a positive history of allergic conjunctivitis and positive skin test reaction to allergens * be willing to avoid disallowed medications for the appropriate washout period and throughout the trial * be willing to avoid contact lens use * be willi...