NCT07745062 The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free
| NCT ID | NCT07745062 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gordon Schanzlin New Vision |
| Condition | Dry Eye Disease (DED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-17 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2026-07-17 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
David I Geffen, Doctor Of Optometry
PRINCIPAL INVESTIGATOR
Gordon Schanzlin New Vision Institute
Frequently Asked Questions
Who can join the NCT07745062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Disease (DED). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07745062 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07745062 currently recruiting?
Yes, NCT07745062 is actively recruiting participants. Contact the research team at rowen@gwsvision.com for enrollment information.
Where is the NCT07745062 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07745062 clinical trial?
NCT07745062 is sponsored by Gordon Schanzlin New Vision. The principal investigator is David I Geffen, Doctor Of Optometry at Gordon Schanzlin New Vision Institute. The trial plans to enroll 30 participants.