NCT01967147

Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects

Evaluation of Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects With Lipid Deficiency

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.

Detailed description

This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Propylene Glycol, 0.6% eye drops	Commercially available eye drops used during Treatment Phase
DRUG	Preservative-free 0.9% Saline solution	Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-10-22
• Last updated: 2016-03-23
• Results posted: 2016-03-23