Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Ocular Therapeutix

Status and phase

Completed

Phase 2

Conditions

Ocular Inflammation and Pain

Treatments

Drug: Placebo Vehicle Punctum Plug

Drug: OTX-DP (Dexamethasone punctum plug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01666210

OTX-12-002

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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