OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease

Inclusion Criteria:

• Had a known history of dry eye disease
• Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

Exclusion Criteria:

• History of intraocular inflammation in either eye
• Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
• Uncontrolled glaucoma or is on medications to treat glaucoma
• History of IOP spikes in either eye
• Active epiphora