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Also known as 011516X (New Artificial Tear Formulation)
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 developed by AbbVie Inc. (ticker ABBV) as a new artificial tear formulation for dry eye disease. It has been studied in a Phase 3 clinical trial comparing it with Systane Ultra Multidose in adults with dry eye disease.
011516X is being developed for dry eye disease (DED), a condition in which the eyes do not produce adequate tears or tears evaporate too quickly. The Phase 3 study enrolled 400 participants aged 18 years and older with dry eye disease in the United States.
AbbVie Inc., which trades under the ticker ABBV, is the developer of 011516X. The company is studying the asset as a new artificial tear formulation for dry eye disease.
011516X is in Phase 3 development. Its single Phase 3 trial, NCT04393441, has been completed, and no trials of the drug are currently listed as active. The drug is investigational and is not approved for commercial use.
011516X has been evaluated in one Phase 3 trial, NCT04393441, titled Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease. The completed study enrolled 400 participants in the United States and used an active-controlled, randomized design.
Yes. 011516X is also known as 011516X (New Artificial Tear Formulation). Both names refer to the same AbbVie Inc. (ABBV) investigational small molecule being studied for dry eye disease in the Phase 3 trial NCT04393441.