Overview

OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ocular Therapeutix, Inc.
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
Inclusion Criteria:

- Has a cataract and is expected to undergo clear corneal cataract surgery with
phacoemulsification and implantation of posterior chamber lens

- Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or
better in both eyes

Exclusion Criteria:

- Any intraocular inflammation in the study eye present during the screening slit lamp
examination

- Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening

- Any intraocular inflammation in the study eye present during the screening slit lamp
examination