Dry Eye Disease (DED)Phase 4SYSTANEvBLINKNCT07745062
The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free
A Phase 4 study testing Systane PRO and Blink tears in people with Dry Eye Disease (DED), run by Gordon Schanzlin New Vision at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Systane PRO and Blink tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2026to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Gordon Schanzlin New Vision Institute
La Jolla, California, 92037
Rylee Owen, 858-455-6800, rowen@gwsvision.com
David I Geffen, Doctor Of Optometry
About this study
Official title: The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free in Providing Relief From Multiple Symptoms of Dry Eye Disease, and Its Impact on Daily Functioning and Overall Comfort in Dry Eye Subjects
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.
Read the detailed description
This is a prospective, randomized, controlled, crossover study designed to compare the effectiveness of preservative-free Systane PRO Preservative Free and Blink Triple Care Preservative Free in improving the signs and symptoms of mild-to-moderate Dry Eye Disease. Approximately 80 adults (≥18 years) with an OSDI score of 13-32 and best-corrected visual acuity of 20/32 or better will be enrolled.
Participants will complete a 1-week artificial tear washout period prior to enrollment. Subjects will then be randomized to receive either Systane PRO Preservative Free or Blink Triple Care Preservative Free, instilled four times daily in both eyes for 30 days. Following a 1-week washout period, subjects will cross over to the alternate treatment for an additional 30 days.
Participants will attend five study visits (Baseline, Day 7, Day 30, Day 44, and Day 67) and complete a daily dosing diary to monitor treatment compliance. At each visit, assessments will include the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness (SPEED) questionnaires, best-corrected visual acuity, non-invasive tear breakup time (NI-TBUT), corneal fluorescein staining (CFS), and adverse event evaluation. Refraction will be performed at baseline only.
The primary efficacy analyses will evaluate changes in dry eye symptoms (OSDI and SPEED) and objective tear film measures (NI-TBUT and CFS) from baseline through each treatment period, with direct comparison between the two artificial tear formulations. Visual acuity is expected to remain stable throughout the study. An interim analysis will be conducted after the first 30 participants have completed enrollment to determine whether the study should continue to full enrollment based on evidence of a meaningful treatment difference.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Systane PRO, Blink tears
- Keywords
- Dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane PRODrug
Administer Systane Pro PF QID OU over a period of 30 days
Blink tearsDrug
Administer Blink Triple Care PF QID OU over a period of 30 days
| Study group | Role | What they receive |
|---|---|---|
| BLINK TRIPLE CARE PF | Active comparator | administer Blink Triple care PF QID OU over a period of 30 days Receives: Drug: Blink tears |
| Systane PRO PF | Experimental | Administer Systane Pro PF QID OU over a period of 30 days Receives: Drug: Systane PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = Some of the time
- = Half of the time
- = Most of the time
- = All of the time
Measured: 30 days
Secondary outcomes (1)
Standard Patient Evaluation of Eye Dryness (SPEED)
Change in patient reported dry eye symptoms (SPEED) from baseline to Day 30
Patients report symptoms including:
Dryness Grittiness or scratchiness Soreness or irritation Burning or watering Eye fatigue
Frequency Score: 0-4 Severity Score: 0-4 Total SPEED Score: 0-28
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start17 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Approximately 80 participants will be randomized to one of two treatment sequences. Participants will receive either Systane PRO PF or Blink Triple Care PF for 30 days, followed by a one-week washout period before crossing over to the alternate treatment for an additional 30 days.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gordon Schanzlin New Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David I Geffen, OD,FAAo, Gordon Schanzlin New Vision
- Investigators
- David I Geffen, Doctor Of Optometry, Principal investigator, Gordon Schanzlin New Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745062
- Sponsor's protocol ID
- 103233847
- Acronym
- SYSTANEvBLINK
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free in Providing Relief From Multiple Symptoms of Dry Eye Disease, and Its Impact on Daily Functioning and Overall Comfort in Dry Eye Subjects
- ClinicalTrials.gov ID
- NCT07745062
- Acronym / sponsor ID
- SYSTANEvBLINK / 103233847
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry eye disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gordon Schanzlin New VisionUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, controlled, crossover study designed to compare the effectiveness of preservative-free Systane PRO Preservative Free and Blink Triple Care Preservative Free in improving the signs and symptoms of mild-to-moderate Dry Eye Disease. Approximately 80 adults (≥18 years) with an OSDI score of 13-32 and best-corrected visual acuity of 20/32 or better will be enrolled.
Participants will complete a 1-week artificial tear washout period prior to enrollment. Subjects will then be randomized to receive either Systane PRO Preservative Free or Blink Triple Care Preservative Free, instilled four times daily in both eyes for 30 days. Following a 1-week washout period, subjects will cross over to the alternate treatment for an additional 30 days.
Participants will attend five study visits (Baseline, Day 7, Day 30, Day 44, and Day 67) and complete a daily dosing diary to monitor treatment compliance. At each visit, assessments will include the Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness (SPEED) questionnaires, best-corrected visual acuity, non-invasive tear breakup time (NI-TBUT), corneal fluorescein staining (CFS), and adverse event evaluation. Refraction will be performed at baseline only.
The primary efficacy analyses will evaluate changes in dry eye symptoms (OSDI and SPEED) and objective tear film measures (NI-TBUT and CFS) from baseline through each treatment period, with direct comparison between the two artificial tear formulations. Visual acuity is expected to remain stable throughout the study. An interim analysis will be conducted after the first 30 participants have completed enrollment to determine whether the study should continue to full enrollment based on evidence of a meaningful treatment difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Approximately 80 participants will be randomized to one of two treatment sequences. Participants will receive either Systane PRO PF or Blink Triple Care PF for 30 days, followed by a one-week washout period before crossing over to the alternate treatment for an additional 30 days.
| Arm | Type | Receives |
|---|---|---|
| BLINK TRIPLE CARE PF | Active comparator | Drug: Blink tearsadminister Blink Triple care PF QID OU over a period of 30 days |
| Systane PRO PF | Experimental | Drug: Systane PROAdminister Systane Pro PF QID OU over a period of 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systane PROAdminister Systane Pro PF QID OU over a period of 30 days | Drug | Systane PRO PF |
| Blink tearsAdminister Blink Triple Care PF QID OU over a period of 30 days | Drug | BLINK TRIPLE CARE PF |
Primary outcome
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
1 secondary outcome
Standard Patient Evaluation of Eye Dryness (SPEED)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David I Geffen, Doctor Of Optometry principal investigator
Gordon Schanzlin New Vision Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Systane PRO and Blink tears in people with Dry Eye Disease (DED), run by Gordon Schanzlin New Vision at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rylee Owen (858-455-6800, rowen@gwsvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.