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

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.

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