Dry Eye Disease (DED)Phase 4SYSTANEPRO1NCT07639034
Effectiveness of Systane PRO for Mild to Moderate Dry Eye Disease
A Phase 4 study testing Systane Pro Topical Ophthalmic in people with Dry Eye Disease (DED), run by Gordon Schanzlin New Vision at 1 site in United States.
Trial summary
The primary objective of this study is to show that consistent use of Systane PRO over a 30 period will significantly improve the signs and symptoms of Dry Eye Disease and decrease patients' ocular surface disease index score for patients diagnosed with mild-moderate (DED). 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 Topical Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients aged 18 and older with mild-moderate DED (as determined by an OSDI score between 13-22).
Who cannot join
- Patients unwilling to discontinue all concomitant ophthalmic medications and dry eye therapies for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gordon Schanzlin New Vision Institute
La Jolla, California, 92037
About this study
Official title: The Effectiveness of Systane PRO in Providing Relief From Multiple Symptoms of Dry Eye Disease and Its Impact on Daily Functioning and Overall Comfort in Patients With Mild to Moderate Dry Eye Disease
The primary objective of this study is to show that consistent use of Systane PRO over a 30 period will significantly improve the signs and symptoms of Dry Eye Disease and decrease patients' ocular surface disease index score for patients diagnosed with mild-moderate (DED).
Read the detailed description
30 eligible participants with mild-moderate dry eye disease (DED) will be enrolled based on predefined Inclusion/Exclusion criteria. All assessments are performed on Day 0, capturing the initial status of several subject-reported symptoms and clinical features of DED. Participants will then commence daily administration of Systane PRO, QID, will be reassessed after 30 days of continuous use. All initial assessments will be repeated on Day 30 to generate paired data for all subject-reported and clinical data. This paired design will minimize cross-subject variability and improve the statistical power of the study.
Subject-reported symptoms of DED will be assessed by: the Ocular Surface Disease Index (OSDI) questionnaire, the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, Visual Analog Scale (VAS) Questionnaires for Ocular Stinging and Grittiness, and the Work Productivity and Activity Impairment (WPAI) questionnaire for DED. These instruments provide comprehensive insight into patient experience, capturing frequency, severity, and the daily impact of symptoms.
Clinical measurements include: LogMAR-converted Best-Corrected Distance Visual Acuity (BCDVA), Corneal Fluorescein Staining (NEI Scale), and Tear Breakup Time 6 of 13 (TBUT). Collectively, these clinical measurements will serve as secondary endpoints for this study and will be used to corroborate any changes observed in the primary endpoint, change in OSDI score.
Additionally, a Manifest Refraction will be performed once at baseline to assess BCDVA, the same refraction will be used to assess BCDVA at Day 30. A Wratten-12 filter will be utilized for Corneal Fluorescein Staining Grading and Tear Breakup Time assessments to facilitate accurate visualization of the tear film.
At study completion, changes from baseline in both subjective and objective measures are systematically analyzed according to the Statistical Analysis Plan.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- Systane Pro Topical Ophthalmic
- Keywords
- dry eyes,
- 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 Pro Topical OphthalmicDrug
To show that consistent use of Systane PRO will significantly improve the signs and symptoms of Dry Eye Disease in patients with mild-moderate DED.
| Study group | Role | What they receive |
|---|---|---|
| The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and | Experimental | Not described Receives: Drug: Systane Pro Topical Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Day 30
The OSDI is a validated 12-item questionnaire used to assess dry eye symptoms and their impact on vision-related functioning. Scores range from 0 to 100, with higher scores indicating more severe dry eye symptoms and worse ocular surface disease. Lower scores indicate improvement.
Change in OSDI Score will be analyzed with a Wilcoxon signed-rank test comparing Baseline vs. Follow-up. Median change and the proportion of subjects with a ≥4.5-point decrease in score will be reported.
Measured: From enrollment to the end of participation at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Nov 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gordon Schanzlin New Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639034
- Sponsor's protocol ID
- GSNVI-SYSTANEPRO1
- Acronym
- SYSTANEPRO1
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Systane PRO in Providing Relief From Multiple Symptoms of Dry Eye Disease and Its Impact on Daily Functioning and Overall Comfort in Patients With Mild to Moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07639034
- Acronym / sponsor ID
- SYSTANEPRO1 / GSNVI-SYSTANEPRO1
- Conditions
- Dry Eye Disease (DED)
- Keywords
- dry eyes,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gordon Schanzlin New VisionUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 10 Jun 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 primary objective of this study is to show that consistent use of Systane PRO over a 30 period will significantly improve the signs and symptoms of Dry Eye Disease and decrease patients' ocular surface disease index score for patients diagnosed with mild-moderate (DED).
Detailed description
30 eligible participants with mild-moderate dry eye disease (DED) will be enrolled based on predefined Inclusion/Exclusion criteria. All assessments are performed on Day 0, capturing the initial status of several subject-reported symptoms and clinical features of DED. Participants will then commence daily administration of Systane PRO, QID, will be reassessed after 30 days of continuous use. All initial assessments will be repeated on Day 30 to generate paired data for all subject-reported and clinical data. This paired design will minimize cross-subject variability and improve the statistical power of the study.
Subject-reported symptoms of DED will be assessed by: the Ocular Surface Disease Index (OSDI) questionnaire, the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, Visual Analog Scale (VAS) Questionnaires for Ocular Stinging and Grittiness, and the Work Productivity and Activity Impairment (WPAI) questionnaire for DED. These instruments provide comprehensive insight into patient experience, capturing frequency, severity, and the daily impact of symptoms.
Clinical measurements include: LogMAR-converted Best-Corrected Distance Visual Acuity (BCDVA), Corneal Fluorescein Staining (NEI Scale), and Tear Breakup Time 6 of 13 (TBUT). Collectively, these clinical measurements will serve as secondary endpoints for this study and will be used to corroborate any changes observed in the primary endpoint, change in OSDI score.
Additionally, a Manifest Refraction will be performed once at baseline to assess BCDVA, the same refraction will be used to assess BCDVA at Day 30. A Wratten-12 filter will be utilized for Corneal Fluorescein Staining Grading and Tear Breakup Time assessments to facilitate accurate visualization of the tear film.
At study completion, changes from baseline in both subjective and objective measures are systematically analyzed according to the Statistical Analysis Plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and | Experimental | Drug: Systane Pro Topical Ophthalmic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and older with mild-moderate DED (as determined by an OSDI score between 13-22).
Key exclusion criteria (1 listed)
- Patients unwilling to discontinue all concomitant ophthalmic medications and dry eye therapies for the duration of the study.
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 Pro Topical OphthalmicTo show that consistent use of Systane PRO will significantly improve the signs and symptoms of Dry Eye Disease in patients with mild-moderate DED. | Drug | The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and |
Primary outcome
Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Day 30
Time frame: From enrollment to the end of participation at 28 days
The OSDI is a validated 12-item questionnaire used to assess dry eye symptoms and their impact on vision-related functioning. Scores range from 0 to 100, with higher scores indicating more severe dry eye symptoms and worse ocular surface disease. Lower scores indicate improvement. Change in OSDI Score will be analyzed with a Wilcoxon signed-rank test comparing Baseline vs. Follow-up. Median change and the proportion of subjects with a ≥4.5-point decrease in score will be reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Topical Ophthalmic 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 1 inclusion and 1 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 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Day 30 (time frame: From enrollment to the end of participation at 28 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 17 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.