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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Pro Topical Ophthalmic | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of participation at 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gordon Schanzlin New Vision Institute | La Jolla | California | 92037 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2025 | Jun 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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