Dry Eye Disease (DED)
Conditions
Keywords
dry eyes,
Brief 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).
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.
Interventions
DRUGSystane 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.
Sponsors
Gordon Schanzlin New Vision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Day 30 | 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. |
Countries
United States
Outcome results
None listed