To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01160133

Enrollment

Registered

2010-07-12

Start date

2010-07-31

Completion date

2011-06-30

Last updated

2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye

Brief summary

This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

Interventions

OTHERSystane

Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)

OTHERRefresh Tears

Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question. * A sodium fluorescein corneal staining sum of ≥ 3 in either eye. * A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion criteria

* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. * Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study. * A history of intolerance or hypersensitivity to any component of the study medications.

Design outcomes

Primary

Measure	Time frame	Description
To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.	Baseline to visit 3 (Day 42)	This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026