Overview

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

Status:
Completed
Trial end date:
2015-11-01
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 dry eye disease
Phase:
Phase 2
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:

- 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