Dry EyePhase 4NCT06219577
Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
A Phase 4 study testing Systane Complete Multi-Dose PF and Walgreen's Lubricant Balance in people with Dry Eye, run by Scripps Poway Eyecare and Optometry at 1 site in United States.
Trial summary
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Systane Complete Multi-Dose PF and Walgreen's Lubricant Balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 22 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
- Subjects between the ages of 18-65.
- Subjects willing to comply with the prescribed regimen and schedule of eye drops.
- Subjects willing to attend all study visits.
- Subjects willing to discontinue any current artificial tear use 24 hours prior to the baseline study visit.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease.
- History of herpetic keratitis or ocular surgery.
- Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
- Recent (within 1 year) blepharitis debridement procedure including BlephEx.
- Screening SANDE score > 55 (equivalent to OSDI score of >32).2 This is indicative of a severe dry eye.
Show all 13Show fewer
- Screening SANDE score < 20 (equivalent to OSDI score of <12).2 This is indicative of a clinically normal eye.
- Screening non-invasive TBUT < 2 seconds, or > 10 seconds.3
- Screening NaFl score < 3 (clinically normal eye) or > 10 (severe dry eye).4
- Pregnant or lactating.
- Current use of contact lenses.
- Any change in eye drop regimen, whether OTC or RX in the last 90 days.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Poway Eyecare & Optometry
San Diego, California, 92131
About this study
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
- Conditions
- Dry Eye
- Being tested
- Systane Complete Multi-Dose PF, Walgreen's Lubricant Balance
- 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 Complete Multi-Dose PFDrug
Eyedrop
Walgreen's Lubricant BalanceDrug
Eyedrop
| Study group | Role | What they receive |
|---|---|---|
| Systane Complete Multi-Dose PF | Other | Not described Receives: Drug: Systane Complete Multi-Dose PF |
| Walgreen's Lubricant Balance | Other | Not described Receives: Drug: Walgreen's Lubricant Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANDE Questionnaire
The Symptom Assessment iN Dry Eye (SANDE) questionnaire.
Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root[Q1 * Q2].
Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.
Measured: Change from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start18 Jan 2024
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Poway Eyecare and Optometry
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Jay Mashouf, OD, Principal investigator, Scripps Poway Eyecare & Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219577
- Sponsor's protocol ID
- JM-23-02
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2024
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance
- ClinicalTrials.gov ID
- NCT06219577
- Acronym / sponsor ID
- JM-23-02
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Scripps Poway Eyecare and OptometryUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single site, prospective, double-masked, randomized-controlled, two-arm study of the dry eye symptoms as well as corneal and conjunctival staining in subjects using 2 different eyedrops. Subjects will be assessed at a screening visit, and 2 follow-up visits. Clinical evaluations will include patient questionnaire, tear-breakup time, and slit lamp exam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Complete Multi-Dose PF | Other | Drug: Systane Complete Multi-Dose PF |
| Walgreen's Lubricant Balance | Other | Drug: Walgreen's Lubricant Balance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Note: Ocular criteria must be met in both eyes.
- Subjects who currently have mild to moderate symptoms of dry eye as defined by a screening SANDE score of 20-55 inclusive (equivalent to OSDI score of 12 -32).2
- Subjects between the ages of 18-65.
- Subjects willing to comply with the prescribed regimen and schedule of eye drops.
- Subjects willing to attend all study visits.
Key exclusion criteria (13 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular anterior segment infection, inflammation, abnormality, or active disease.
- History of herpetic keratitis or ocular surgery.
- Recent (within 1 year) thermal meibomian gland expression procedure including Lipiflow, iLux, or TearCare.
- Recent (within 1 year) blepharitis debridement procedure including BlephEx.
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 Complete Multi-Dose PFEyedrop | Drug | Systane Complete Multi-Dose PF |
| Walgreen's Lubricant BalanceEyedrop | Drug | Walgreen's Lubricant Balance |
Primary outcome
SANDE Questionnaire
Time frame: Change from baseline to 2 weeks
The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root[Q1 * Q2]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
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. This study is not recruiting at the moment.
Jay Mashouf, OD principal investigator
Scripps Poway Eyecare & Optometry
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 Complete Multi-Dose PF and Walgreen's Lubricant Balance in people with Dry Eye, run by Scripps Poway Eyecare and Optometry 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 7 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: finished, as of the sponsor's last update on 8 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SANDE Questionnaire (time frame: Change from baseline to 2 weeks). 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 8 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.