Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance

NCT ID: NCT06219577

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-04-22

Brief Summary

Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.

Conditions

Dry Eye

Study Design

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

Study Groups

Systane Complete Multi-Dose PF

Group Type: OTHER

Systane Complete Multi-Dose PF

Intervention Type: DRUG

Eyedrop

Walgreen's Lubricant Balance

Group Type: OTHER

Walgreen's Lubricant Balance

Intervention Type: DRUG

Eyedrop

Interventions

Systane Complete Multi-Dose PF

Eyedrop

Intervention Type: DRUG

Walgreen's Lubricant Balance

Eyedrop

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
• Subjects between the ages of 18-65.
• Subjects willing to comply with the prescribed regimen and schedule of eye drops.
• Subjects willing to attend all study visits.
• Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.

Exclusion Criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease.
• History of herpetic keratitis or ocular surgery.
• Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
• Recent (within 1 year) blepharitis debridement procedure including BlephEx.
• Screening SANDE score > 55 (equivalent to OSDI score of >32).2 This is indicative of a severe dry eye.
• Screening SANDE score < 20 (equivalent to OSDI score of <12).2 This is indicative of a clinically normal eye.
• Screening non-invasive TBUT < 2 seconds, or > 10 seconds.3
• Screening NaFl score < 3 (clinically normal eye) or > 10 (severe dry eye).4
• Pregnant or lactating.
• Current use of contact lenses.
• Any change in eye drop regimen, whether OTC or RX in the last 90 days.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Scripps Poway Eyecare and Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Mashouf, OD

Role: PRINCIPAL_INVESTIGATOR

Scripps Poway Eyecare & Optometry

Locations

Scripps Poway Eyecare & Optometry

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JM-23-02

Identifier Type: -

Identifier Source: org_study_id