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Completed

NCT Number: NCT06219577

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scripps Poway Eyecare & Optometry

San Diego, California, 92131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Systane Complete Multi-Dose PF

Drug

Eyedrop

Walgreen's Lubricant Balance

Drug

Eyedrop

Primary outcomes

  1. SANDE Questionnaire

    Time frame: Change from baseline to 2 weeks

    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.

Other outcomes

  1. Corneal and Conjunctival Staining

    Time frame: Change from baseline to 2 weeks

    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 (by summation) of 0-15 per eye. A higher score is a worse outcome.

  2. Non-invasive Tear Breakup Time

    Time frame: Change from baseline to 2 weeks

Sponsors and collaborators

Lead sponsor

Scripps Poway Eyecare and Optometry

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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