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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Systane Complete Multi-Dose PF; Drug: Walgreen's Lubricant Balance

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Leslie Shan; Phone Number: 858-530-2800; Email: lshanod@gmail.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • Scripps Poway Eyecare & Optometry
      • Principal Investigator: Jay Mashouf, OD
      • Contact: Leslie Shan; Phone Number: 858-530-2800; Email: lshanod@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Systane Complete Multi-Dose PF	Drug: Systane Complete Multi-Dose PF; Eyedrop
Other: Walgreen's Lubricant Balance	Drug: Walgreen's Lubricant Balance; Eyedrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SANDE Questionnaire	Subjects are asked to place an 'X' on the line to indicate the frequency and severity of their dry eye symptoms. Higher scores on the questionnaire indicate more frequent or severe dry eye symptoms.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal and conjunctival staining	Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score of 0-15 per eye.	2 weeks
Non-invasive tear breakup time		2 weeks

Collaborators and Investigators

• Sponsor: Scripps Poway Eyecare and Optometry
• Collaborators: Sengi
• Investigators: Principal Investigator: Jay Mashouf, OD, Scripps Poway Eyecare & Optometry

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Actual): April 22, 2024
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: JM-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No