Clinical Trials Directory

Trials / Completed

CompletedNCT02470429

Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye

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

Summary

The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Detailed description

Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Conditions

Interventions

TypeNameDescription
DEVICESYSTANE HYDRATION lubricant eye dropsPreserved with POLYQUAD (polidronium chloride) 0.001%
DEVICEHyabak 0.15% eye dropsPreservative-free
DRUG0.9% saline eye dropsPreservative-free, one drop 4 times a day in each eye (run-in period)

Timeline

Start date
2015-07-17
Primary completion
2016-05-26
Completion
2016-05-26
First posted
2015-06-12
Last updated
2018-07-02
Results posted
2017-06-16

Source: ClinicalTrials.gov record NCT02470429. Inclusion in this directory is not an endorsement.