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

• ClinicalTrials.gov Identifier: NCT00388791
• Recruitment Status: Completed
• First Posted: October 17, 2006
• Last Update Posted: January 28, 2016
• Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
• Information provided by: Southern California College of Optometry at Marshall B. Ketchum University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Dry Eye	Drug: Systane Free	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Comparison of Systane Free vs. Saline in the Treatment of Dry Eye
• Study Start Date: October 2006
• Actual Study Completion Date: April 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Ocular health measures, including corneal staining and rose bengal staining
2. Symptom scores using the Schein questionnaire
3. Tear breakup time

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 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.

Contacts and Locations

Locations

United States, California

Southern California Colleg of Optometry

Fullerton, California, United States, 92831

Sponsors and Collaborators

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

More Information

• ClinicalTrials.gov Identifier: NCT00388791
• Other Study ID Numbers: 05-S4507
• First Posted: October 17, 2006
• Last Update Posted: January 28, 2016
• Last Verified: January 2016

Keywords provided by Southern California College of Optometry at Marshall B. Ketchum University:

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