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

NCT06219577 | Completed Phase 4 Results FDA Drug

• 1 other identifier: JM-23-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• SANDE Questionnaire

  The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.

  Change from baseline to 2 weeks

Other Outcomes (2)

• Corneal and Conjunctival Staining

  Change from baseline to 2 weeks

• Non-invasive Tear Breakup Time

  Change from baseline to 2 weeks

Study Arms (2)

Systane Complete Multi-Dose PF

OTHER

Drug: Systane Complete Multi-Dose PF

Walgreen's Lubricant Balance

OTHER

Drug: Walgreen's Lubricant Balance

Interventions

Systane Complete Multi-Dose PF DRUG

Eyedrop

Systane Complete Multi-Dose PF

Walgreen's Lubricant Balance DRUG

Eyedrop

Walgreen's Lubricant Balance

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Poway Eyecare and Optometry: lead
• Sengi: collaborator

Study Sites (1)

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr Jay Mashouf
• Organization: Scripps Optometric Group

jaymashouf@gmail.com

18585302800

Study Officials

• Jay Mashouf, OD

  Scripps Poway Eyecare & Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: January 18, 2024
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)