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

S

Scripps Poway Eyecare and Optometry

Status and phase

Enrolling
Phase 4

Conditions

Dry Eye

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06219577
JM-23-02

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups

Systane Complete Multi-Dose PF
Other group
Treatment:
Drug: Systane Complete Multi-Dose PF
Walgreen's Lubricant Balance
Other group
Treatment:
Drug: Walgreen's Lubricant Balance

Trial contacts and locations

0

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Central trial contact

Leslie Shan

Data sourced from clinicaltrials.gov

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