Double-masked two period controlled trial of three eyelid wipe dosing techniques

This is a randomized, single center, single -masked study to evaluate the safety, tolerability, and efficacy of IVW-1001 Ophthalmic Eyelid Wipe dosing techniques in subjects with DED. Treatments will be IVW 1001 Ophthalmic Eyelid Wipe 0.2% (low dose) and 0.4% (high dose). Subjects will participate in a 50-day, double -masked three dosing technique comparisons period using IVW-1001 Ophthalmic Eyelid Wipe 0.2% followed by a 14-day between period washout.

Inclusion Criteria:

• Self-reported diagnosis of DED in one or both eyes
• BCVA +0.70 logarithm of minimum angle of refraction (Snellen equivalent 20/100) or better in each eye at the Screening Visit
• For women of childbearing potential, confirmed negative pregnancy test at the Screening Visit, not nursing a child, and willing to comply with one of the acceptable methods of birth control described in the protocol
• History (by subject recollection) of artificial tear use within 30 days prior to the Screening Visit
• Unanesthetized Schirmer's test score 5-19 mm inclusive in at least 1 eye (same eye) at the Screening Visit and the Baseline Visit

Exclusion Criteria:

• Corneal fluorescein staining score of 4 in either eye in any zone using the National Eye Institute grading system at either the Screening Visit or the Baseline Visit
• IOP ≥23 mmHg in either eye at either the Screening Visit or the Baseline Visit
• History of glaucoma or ocular hypertension in either eye requiring past or current medical or surgical intervention

All site personnel will be aware of the assigned IVW-1001 Ophthalmic Eyelid Wipe 0.2% concentration. However, subjects will be randomized to the sequence of the assigned dosing technique procedures which will be provided to individual subjects by the unmasked dosing technique coordinator only