NCT04393441

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

A Multicenter, Single-masked, Randomized Study 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	011516X (New Artificial Tear Formulation)	Topical eye drops
DRUG	Systane Ultra Multidose	Topical eye drops
DRUG	REFRESH PLUS®	Topical eye drops

Timeline

• Start date: 2020-06-29
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2020-05-19
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study