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

Dry Eye Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

A 15-day Run-in phase will precede a 90-day Treatment period. The Treatment period will be conducted in 2 phases. In Phase 1, participants will be randomized to either Systane® Balance or Saline and dose 4 times a day for 35 days. In Phase II (Day 35-90) participants will continue to dose with their assigned product on an as-needed basis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01967147
Study type Interventional
Source Alcon Research
Contact
Status Completed
Phase N/A
Start date February 2014
Completion date January 2015
View Details
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