Status:
COMPLETED
Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
Lead Sponsor:
Scripps Poway Eyecare and Optometry
Collaborating Sponsors:
Sengi
Conditions:
Dry Eye
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06219577
Start Date
January 18 2024
End Date
April 22 2024
Last Update
April 8 2025
Active Locations (1)
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1
Scripps Poway Eyecare & Optometry
San Diego, California, United States, 92131