Overview

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