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011516X · 1 trial · 1 indication
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...
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011516X is an investigational small molecule being developed for Dry Eye Disease (DED). It is designed to address the signs and symptoms of dry eye, a condition characterized by insufficient tear production or excessive tear evaporation. The drug is currently in Phase 3 clinical development, though the specific mechanism of action has not been disclosed.
011516X is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of 011516X for the treatment of Dry Eye Disease.
011516X is in Phase 3 clinical development for Dry Eye Disease. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
011516X has one completed Phase 3 clinical trial, identified as NCT04393441. This trial evaluated the efficacy and safety of 011516X compared with Systane Ultra Multidose in 400 participants with Dry Eye Disease. The study was conducted in the United States and enrolled adults aged 18 years and older.
011516X is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Dry Eye Disease. The completed Phase 3 trial, NCT04393441, compared 011516X with an active control, but regulatory approval has not been granted.