The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free
SYSTANEvBLINK
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2026
CompletedFirst Submitted
Initial submission to the registry
July 22, 2026
CompletedFirst Posted
Study publicly available on registry
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
August 4, 2026
July 1, 2026
6 months
July 22, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular Surface Disease Index (OSDI)
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
30 days
Secondary Outcomes (1)
Standard Patient Evaluation of Eye Dryness (SPEED)
30 days
Study Arms (2)
BLINK TRIPLE CARE PF
ACTIVE COMPARATORadminister Blink Triple care PF QID OU over a period of 30 days
Systane PRO PF
EXPERIMENTALAdminister Systane Pro PF QID OU over a period of 30 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gordon Schanzlin New Vision Institute
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David I Geffen, Doctor Of Optometry
Gordon Schanzlin New Vision Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2026
First Posted
August 4, 2026
Study Start
July 17, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
August 4, 2026
Record last verified: 2026-07