# Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease

> **NCT04393441** · PHASE3 · COMPLETED · sponsor: **Allergan** · enrollment: 400 (actual)

## Conditions studied

- Dry Eye Disease (DED)

## Interventions

- **DRUG:** 011516X (New Artificial Tear Formulation)
- **DRUG:** Systane Ultra Multidose
- **DRUG:** REFRESH PLUS®

## Key facts

- **NCT ID:** NCT04393441
- **Lead sponsor:** Allergan
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-06-29
- **Primary completion:** 2021-06-15
- **Final completion:** 2021-06-15
- **Target enrollment:** 400 (ACTUAL)
- **Last updated:** 2024-06-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04393441

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04393441, "Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease". Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/clinical/NCT04393441. Licensed CC0.

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