Clinical trial NCT06219577: Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
Official title: Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Scripps Poway Eyecare and Optometry
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \< 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.

Primary outcomes:
measure: SANDE Questionnaire
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
Other outcomes:
measure: Corneal and Conjunctival Staining
timeFrame: Change from baseline to 2 weeks
measure: Non-invasive Tear Breakup Time
timeFrame: Change from baseline to 2 weeks
Locations:
city: San Diego
country: United States
facility: Scripps Poway Eyecare & Optometry
state: California
Study officials:
affiliation: Scripps Poway Eyecare & Optometry
name: Jay Mashouf, OD
role: PRINCIPAL_INVESTIGATOR
References: