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

• Status: Completed
• Trial end date: 2016-04-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Collaborator: ORA, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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