Comparison of Systane Free vs. Saline in the Treatment of Dry Eye

January 26, 2016 updated by: Southern California College of Optometry at Marshall B. Ketchum University
The purpose of this study is to compare the efficacy of Systane Free to Saline in decreasing the symptoms of dry eye after aggressive therapy. As a principal outcome measure, we are using the modified Schein dry eye symptomatology questionaire to determine whether any improvement in signs is mirrored by improvement in the Schein Score. Up to 30 dry eye subjects will be dosed six times per day for one month. The typical clinical signs will be onmitored (e.g., corneal staining) along with dyrness symptoms. The hypothesis is that an optimized drop, Systane Free, will be more effective than saline solution in improving dry eye signs and symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92831
        • Southern California Colleg of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The informed consent document must be read, signed and dated by the subject or legally authorized representative before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the subject.

Adult subjects with mild to moderate dry eye. Criteria for the diagnosis must include two of the three following characteristics as demonstrated at the Eligibility Visit:

Composite symptom score of greater than or equal to 7 on the Schein Questionnaire.

Sodium Fluorescein (NaFl) Tear Break-Up Time less than 7 seconds in both eyes. Cumulative Sodium Fluorescein Corneal Staining greater than or equal to 4 in both eyes on a 0 to 20 point scale.

Rose Bengal corneal staining greater than 4 of 24 maximum for 6 zones. Able and willing to follow study instructions. Subjects must have best corrected visual acuity of twenty twenty five or better in each eye.

The informed consent document must be read, signed and dated by the subject or legally authorized representative before conducting any procedures. Additionally, the informed consent document must be signed and dated by the individual obtaining consent of the subject.

Adult subjects with mild-to-moderate dry eye. Criteria for the diagnosis must include two of the three following characteristics as demonstrated at the Eligibility Visit

Composite symptom score of greater than or equal to 7 on the Schein Questionnaire.

Sodium FluoresceinTear Break-Up Time less than or equal to 7 seconds in both eyes.

Cumulative Sodium Fluorescein Corneal Staining greater than or equal to 4 in both eyes on a 0 to 20 point scale.

Rose Bengal corneal staining greater than 4 of 24 maximum for 6 zones. Able and willing to follow study instructions. Subjects must have best corrected visual acuity of twenty twenty five or better in each eye.

Exclusion Criteria:

History or evidence of ocular or intraocular surgery in either eye within the past six months. LASIK and other keratorefractive procedure patients may participate if the surgery was earlier than 12 months at the time of the beginning of the study.

History or evidence of serious ocular trauma in either eye within the past six months.

History of hypersensitivity to any component of the study medications. These include the artificial tear and the diagnostic dye sodium fluorescein.

History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.

Use of topical ocular medications during the study period. Subjects using systemic steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in the study if they have not been on a stable dosing regimen for a minimum of 30 days prior to the Eligibility Visit. In addition, the dosing regimen must remain stable throughout the 4-week treatment period.

Ocular conditions such as active acute conjunctival infections or iritis. Individuals unwilling to discontinue contact lens wear for seven days prior to the study and throughout the study.

Participation in an investigational drug or device study within 30 days of entering this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ocular health measures, including corneal staining and rose bengal staining
Symptom scores using the Schein questionnaire
Tear breakup time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California College of Optometry at Marshall B. Ketchum University

Investigators

  • Study Director: Jerry R Paugh, Southern California College of Optometry at Marshall B. Ketchum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion

December 7, 2022

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-S4507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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