18 and older, any sex, with Dry Eye Disease (DED). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Total Staining Score at Day 90 in the Study EyePrimary· Baseline (Day 1) and Day 90
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 sev
Group
Value
95% CI
Systane® Ultra Multidose
-4.5
± 0.40
011516X (New Artificial Tear Formulation)
-3.4
± 0.41
Change From Baseline in Current Symptom Survey Total Score at Day 90Secondary· Baseline (Day 1) and Day 90
The Current Symptom Survey is a self-assessed 6-item visual analog scale (VAS) survey that assesses symptoms of dry eye disease (DED) including: burning, dryness, irritation, grittiness/foreign body sensation, blurry/fluctuating vision, overall ocular pain/discomfort. Each individual symptom is rated using a score range of 0=none to 100=maximum. The total score, ranging from 0 to 600, is calculated as the sum of individual symptom scores. A negative change from Baseline indicates improvement in DED symptoms experienced by the participant. This is an overall evaluation not per eye. A MMMR model
Group
Value
95% CI
Systane® Ultra Multidose
-138.5
± 11.46
011516X (New Artificial Tear Formulation)
-136.5
± 11.62
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to 30 days post last dose (up to approximately 147 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to compare the efficacy and safety of a new artificial tear formulation (011516X) with Systane® Ultra Multidose for 90 days in participants with Dry Eye Disease (DED).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 26 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04393441.