NCT07745062 · Gordon Schanzlin New Vision
The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free
(SYSTANEvBLINK)
What this study is about
The goal of this experimental 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.
View original scientific description
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.
Interventions
DRUG
Systane PRO
Administer Systane Pro PF QID OU over a period of 30 days
DRUG
Blink tears
Administer Blink Triple Care PF QID OU over a period of 30 days
Primary outcome measures
Ocular Surface Disease Index (OSDI)
Time frame: 30 days
Change in OSDI score from baseline to Day 30 (non-inferiority) Quantify the severity of dry eye symptoms. Assess the impact of symptoms on vision-related activities. Evaluate the effect of environmental factors on ocular comfort. Monitor changes in symptoms over time and in response to treatment. Ocular Symptoms Light sensitivity Gritty sensation Pain or soreness Blurred vision Poor vision Vision-Related Function Difficulty reading Difficulty driving at night Difficulty working with a computer or ATM Difficulty watching television Environmental Triggers Windy conditions Low humidity Air-conditioned environments Patients report how often they experienced each symptom or limitation during the previous week using a 0-4 scale: 0 = None of the time 1. = Some of the time 2. = Half of the time 3. = Most of the time 4. = All of the time
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- La Jolla, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 4, 2026 · Source of record for eligibility and locations