Phase 4
N=70
Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT06219577 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: SANDE Questionnaire — -7.2; -2.2 score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Systane Complete Multi-Dose PF (Drug); Walgreen's Lubricant Balance (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scripps Poway Eyecare and Optometry
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SANDE Questionnaire |
-7.2; -2.2 | — |
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.
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
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 10 seconds.3
- Screening NaFl score 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.
Data sourced from ClinicalTrials.gov (NCT06219577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.