OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Ocular Therapeutix, Inc.73 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Allergic Conjunctivitis

Interventions

DexamethasoneDRUG

Placebo VehicleOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) * 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