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

This study has been completed.
Sponsor:
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00388791
First received: October 16, 2006
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Dry Eye
Drug: Systane Free
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Systane Free vs. Saline in the Treatment of Dry Eye

Resource links provided by NLM:


Further study details as provided by Southern California College of Optometry:

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

Estimated Enrollment: 30
Study Start Date: October 2006
Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (age greater than 18 years) with mild-to-moderate dry eye. Criteria for the diagnosis must include two of the three following characteristics as demonstrated at the Eligibility (Day 0) Visit:

      • Composite symptom score of ≥ 7 on the Schein Questionnaire.
      • Sodium Fluorescein (NaFl) Tear Break-Up Time ≤ 7 seconds in both eyes.
      • Cumulative Sodium Fluorescein (NaFl) Corneal Staining ≥ 4 in both eyes on a 0-20 point scale.
      • Rose Bengal corneal staining > 4/24 maximum for 6 zones.
    • Able and willing to follow study instructions.
    • Subjects must have best corrected visual acuity of 20/25 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 (age greater than 18 years) with mild-to-moderate dry eye. Criteria for the diagnosis must include two of the three following characteristics as demonstrated at the Eligibility (Day 0) Visit:

      • Composite symptom score of ≥ 7 on the Schein Questionnaire.
      • Sodium Fluorescein (NaFl) Tear Break-Up Time ≤ 7 seconds in both eyes.
      • Cumulative Sodium Fluorescein (NaFl) Corneal Staining ≥ 4 in both eyes on a 0-20 point scale.
      • Rose Bengal corneal staining > 4/24 maximum for 6 zones.
    • Able and willing to follow study instructions.
    • Subjects must have best corrected visual acuity of 20/25 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 (Systane) 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 (7) days prior to the study and throughout the study.
    • Participation in an investigational drug or device study within 30 days of entering this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388791

Locations
United States, California
Southern California Colleg of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Investigators
Study Director: Jerry R Paugh Southern California College of Optometry
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388791     History of Changes
Other Study ID Numbers: 05-S4507
Study First Received: October 16, 2006
Last Updated: April 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California College of Optometry:
symptomatology
Schein questionnaire
fluoresceien staining

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on July 22, 2014