OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)

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 chronic allergic conjunctivitis

Inclusion Criteria:

• Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
• Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

• History of refractive surgery (including LASIK procedures) within the past 2 years
• History of retinal detachment, diabetic retinopathy, or active retinal disease
• Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
• Use any of the disallowed medications during the period indicated
• History of IOP increase as a result of steroid treatment