Title
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Phase
Phase 2Lead Sponsor
Ocular Therapeutix, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Ocular Inflammation and PainIntervention/Treatment
urea ...Study Participants
60To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Sustained and tapered release of dexamethasone from hydrogel punctum plug
Hydrogel punctum plug without dexamethasone
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Placebo punctum plug insertion
Inclusion Criteria: Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule Is greater than or equal to 21 years of age Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens 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 at Screening Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
| Event Type | Organ System | Event Term | Dexamethasone Punctum Plug | Placebo Vehicle Punctum Plug |
|---|
Measure of adverse events over the duration of each subject's participation in the study.
