Conditions: Ocular Inflammation and Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
To 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.

Detailed description:

Arms:
arm 1: Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days arm 2: Placebo punctum plug insertion

Interventions: intervention 1: OTX-DP (Dexamethasone punctum plug) intervention 2: Placebo Vehicle Punctum Plug
Intervention descriptions: intervention 1: Sustained and tapered release of dexamethasone from hydrogel punctum plug intervention 2: Hydrogel punctum plug without dexamethasone

Protocol document: