Table 1 Outcome measures for dry eye disease (DED) patients and control subjects
Efficacy measures | |
|---|---|
Primary: | The percentage of patients with signs of DED progression based on at least 1 level increase in severity level as measured by ITF guidelines. Evidence of disease progression by ITF guidelines will require at least one of the following: • 1-unit increase in total corneal staining • New development of central corneal staining (≥ grade level 1) • Increase in OSDI score by ≥6 points • Increase in blurred vision ≥1 grade (using a 5-point scale) |
Secondary: | • % of patients who are discontinued from the study because they need a therapeutic intervention (i.e., the use of cyclosporine, punctal plugs, oral tetracyclines, topical steroids, topical antibiotic ointments, or oral nutritional supplements) due to dry eye disease progression • % of patients with a ≥ 6 point OSDI increase • % of patients with a 1 unit increase in blurred vision • % of patients with a 2 mm decrease in Schirmer’s test over 5 min • % of patients with at least a 1 grade increase in central or total corneal staining • Reduction in reading speed |
Other: | • Change from baseline in goblet cell density (by impression cytology) • Tear Break-up Time • Tear Cytokines • Dry Eye Patient Survey |
Safety Measures | • Adverse Events, Biomicroscopy, BCVA |