OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

A Randomized, Double-masked, Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

To assess the efficacy and safety of OTX-DED for the short-term treatment of the symptoms of DED

Randomized, double-masked, study to evaluate the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the symptoms of dry eye disease (DED). The subjects will be followed for approximately two months.

Inclusion Criteria:

• VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
• Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
• Unanesthetized Schirmer of > 0 and ≤ 10 mm.
• Must not have used Artificial Tears during the Screening period.
• IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.

Exclusion Criteria:

• Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
• Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) < 5 mmHg or > 24 mmHg.