The DEPOT Study (Dry Eye Prescription Options for Therapy): Assessing the Efficacy and Safety of OTX-DED (Dexamethasone Ophthalmic Insert 0.3 mg) for Intracanalicular Use Compared with Loteprednol Suspension for the Treatment of Episodic Dry Eye.

Purpose: To compare OTX-DED, an investigational dexamethasone intracanalicular insert, to loteprednol 0.5% suspension applied QID for 28 days as treatments for acute exacerbations of dry eye disease in terms of patient symptoms, corneal staining, tear breakup time (TBUT), and ocular redness. Methods: Fifty patients with an acute exacerbation of dry eye with at least grade 1 corneal staining were randomized to receive treatment and were each evaluated in one eye at baseline, two weeks and four weeks with the standard patient evaluation of eye dryness (SPEED) questionnaire, the Oxford Scale for corneal stain, Schulze Scale for ocular redness, and intraocular pressure (IOP). Results: Forty-four patients completed the study. Significant improvement was noted from baseline to both week 2 and 4 for each treatment in SPEED scores, corneal staining, and TBUT. Ocular redness improved significantly from baseline to week 2 for loteprednol and week 4 for both drugs. No significant difference was noted between treatments in any of these evaluations at any time point. Retention (visibility) of the OTX-DED insert was 95% at week 2 and 90% at week 4. IOP rose significantly from baseline to both week 2 and 4 for eyes receiving loteprednol but not for those receiving OTX-DED. Conclusion: OTX-DED significantly improved on both signs and symptoms of eyes suffering from acute exacerbations of dry eye disease. This improvement was similar to that seen with loteprednol 0.5% suspension, a well-accepted treatment for this condition. IOP did not change significantly in patients with OTX-DED. These findings support the use of this unique intracanalicular insert for the treatment of acute dry eye once this product is approved and available for use.