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

NCT ID: NCT00388791

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2007-04-30

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.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Systane Free

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Principal Investigators

Jerry R Paugh

Role: STUDY_DIRECTOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

Southern California Colleg of Optometry

Fullerton, California, United States

Countries

United States

Other Identifiers

05-S4507

Identifier Type: -

Identifier Source: org_study_id