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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219577
• Other study ID #: JM-23-02
• Status: Completed
• Phase: Phase 4
• Start date: January 18, 2024
• Est. completion date: April 22, 2024

Study information

• Verified date: April 2024
• Source: Scripps Poway Eyecare and Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

Drug:
• Systane Complete Multi-Dose PF
Eyedrop
• Walgreen's Lubricant Balance
Eyedrop

Locations

Country	Name	City	State
United States	Scripps Poway Eyecare & Optometry	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Poway Eyecare and Optometry	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corneal and conjunctival staining	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 of 0-15 per eye.	2 weeks
Other	Non-invasive tear breakup time		2 weeks
Primary	SANDE Questionnaire	Subjects are asked to place an 'X' on the line to indicate the frequency and severity of their dry eye symptoms. Higher scores on the questionnaire indicate more frequent or severe dry eye symptoms.	2 weeks