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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04393441 | Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease | PHASE3 | COMPLETED | 400 | — | — | Jun 29, 2020 | Jun 15, 2021 | Jun 26, 2024 | 26 | United States |
The total staining score is the sum of corneal and conjunctival staining score using Modified NEI grading scale. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined total staining score is based on the sum of the five zones on the cornea and six zones on the conjunctiva. Each zone is graded on a 0 to 5 scale (0=no staining; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0 to 55. The higher the score, the worse the dry eye condition. A negative change from Baseline represents a decrease in the severity of staining (improvement). The study eye is defined as the worst eye based on total ocular staining score at Baseline (Day 1). The fellow eye is the other eye. A mixed-effects model repeated measures (MMMR) was used for analyses.
| Arm | Type | Description |
|---|---|---|
| Systane® Ultra Multidose | ACTIVE_COMPARATOR | All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of Systane® Ultra Multidose in each eye 3 times daily for up to 90 days. |
| 011516X (New Artificial Tear Formulation) | EXPERIMENTAL | All participants administered 1 to 2 drops of REFRESH PLUS® 3 times daily in each eye for approximately 7 days during a run-in period prior to randomization on Day 1. Participants then administered 1 to 2 drops of 011516X in each eye 3 times daily for up to 90 days. |
| Name | Type | Description |
|---|---|---|
| 011516X (New Artificial Tear Formulation) | DRUG | Topical eye drops |
| Systane Ultra Multidose | DRUG | Topical eye drops |
| REFRESH PLUS® | DRUG | Topical eye drops |
Inclusion Criteria: * At the Screening (Day -7) and Baseline (Day 1) visits, at least 1 eye must qualify based on corneal and conjunctival staining scores * Have used an artificial tear product for DED within 6 months of the Screening (Day -7) visit * Have ability/agreement to continue to wear exis...