Effectiveness of Systane PRO for Mild to Moderate Dry Eye Disease (SYSTANEPRO1)

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).

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Systane Pro Topical Ophthalmic

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Gordon Schanzlin New Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 and older with mild-moderate DED (as determined by an OSDI score between 13-22).

Exclusion Criteria:

• Patients unwilling to discontinue all concomitant ophthalmic medications and dry eye therapies for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Effectiveness of Systane PRO in providing relief from multiple symptoms of dry eye disease, and	Drug: Systane Pro Topical Ophthalmic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Gordon Schanzlin New Vision

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: dry eyes,
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: GSNVI-SYSTANEPRO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No