Recruiting

Systane PRO vs. BLINK TRIPLE CARE

Sponsor:

Gordon Schanzlin New Vision

Code:

NCT07745062

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Systane PRO

Blink tears

Study Details

Brief summary:

The goal of this investigational study is to determine if Systane PRO Preservative Free is non-inferior to BLINK TRIPLE CARE in the clinically significant improvement of signs and symptoms of dry eye in patients over 4 weeks.

Conditions

Dry Eye Disease (DED)

Study ID

NCT07745062

Start date

Jul 17, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: BLINK TRIPLE CARE PF

administer Blink Triple care PF QID OU over a period of 30 days

experimental: Systane PRO PF

Administer Systane Pro PF QID OU over a period of 30 days

Interventions

Systane PRO

Administer Systane Pro PF QID OU over a period of 30 days

Blink tears

Administer Blink Triple Care PF QID OU over a period of 30 days

Primary outcome measure

  • Ocular Surface Disease Index (OSDI) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Rylee Owen

858-455-6800rowen@gwsvision.com

Locations

Gordon Schanzlin New Vision Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

Rylee Owen

858-455-6800rowen@gwsvision.com

Principal Investigator:

David I Geffen, Doctor Of Optometry

More Information

Sponsor

Gordon Schanzlin New Vision

Last update posted

Aug 4, 2026

Last verified

Jul, 2026

Keywords

  • Dry eye disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Gordon Schanzlin New Vision on 2026-08-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.