Is Systane PRO Preservative Free as good as Blink Triple Care Preservative Free for dry eye symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, crossover study in adults with mild-to-moderate dry eye disease comparing preservative-free Systane PRO and Blink Triple Care. Participants will undergo a 1-week washout, receive one treatment for 30 days, then cross over to the other treatment for another 30 days, with visits at baseline, day 7, day 30, day 44, and day 67. Assessments include OSDI, SPEED, BCVA, NI-TBUT, corneal fluorescein staining, and adverse events to determine changes in symptoms and objective tear film measures. The primary analysis compares changes from baseline between the two artificial tears during each treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: Adults ≥ 18 years.
* Diagnosis: Clinical diagnosis of mild to moderate dry eye disease in at least one eye with OSDI ≥ 13 to ≤ 32 at screening.
* OSDI ≥ 13 to ≤ 32 at screening.
* Objective evidence: NITBUT ≤ 10 seconds in the study eye(s) at screening.
* Ocular surface status: CFS ≤ grade 3 (Oxford or NEI scale) in the study eye(s).
* Stable medications: Systemic medications that may affect tear film must be stable ≥ 30 days prior to screening and expected to remain stable during the study.
* Ability to participate: Able and willing to comply with procedures, attend visits, and provide written informed consent.
* Contraception: Women of childbearing potential must agree to use an acceptable method of contraception for the study duration and have a negative pregnancy test at screening.

Exclusion Criteria:

* Active ocular infection or inflammation unrelated to DED (e.g., bacterial/viral conjunctivitis, active uveitis).
* Severe ocular surface disease beyond typical DED (e.g., severe keratitis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid).
* Excessive corneal staining: CFS \> grade 3 in the study eye(s).
* Recent ocular surgery or procedure: ocular surgery, laser, or punctal occlusion within 6 months prior to screening.
* Current or prior use within 6 months before screening of either study drop (Systane PRO PF or Blink Triple Care PF)
* Contact lens wear: soft or rigid contact lens use within 7 days prior to baseline, or unwillingness to discontinue lenses for the study; consider extending to 14 days if desired.
* Use of topical ophthalmic medications that cannot be discontinued (e.g., topical antibiotics, corticosteroids).
* Recent investigational product use: participation in another interventional trial or investigational product use within 30 days prior to screening.
* Known hypersensitivity: allergy to any component of Systane PRO PF or Blink Triple Care PF.
* Confounding systemic conditions: systemic diseases or medications that, in the investigator's judgment, could significantly affect tear production or ocular surface health (e.g., uncontrolled autoimmune disease, recent initiation/change of systemic medications known to affect tear production within 30 days).
* Severe visual impairment in the study eye(s) not attributable to DED that would interfere with assessments.
* Pregnancy or breastfeeding.
* Investigator discretion: any medical, psychiatric, or social condition that would preclude safe participation or reliable completion of study procedures.

Where it's running

• Gordon Schanzlin New Vision Institute
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: David I Geffen, Doctor Of Optometry — Gordon Schanzlin New Vision Institute
• Study coordinator: Rylee Owen
• Email: rowen@gwsvision.com
• Phone: 858-455-6800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.