NCT02446015

Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Detailed description

This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	SYSTANE® ULTRA Lubricant Eye Drops

Timeline

• Start date: 2015-06-19
• Primary completion: 2016-06-21
• Completion: 2016-06-21
• First posted: 2015-05-15
• Last updated: 2018-07-02
• Results posted: 2017-06-16