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

Ocular Therapeutix, Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ocular Inflammation and Pain

Interventions

OTX-DP (Dexamethasone punctum plug)DRUG

Sustained and tapered release of dexamethasone from hydrogel punctum plug

Placebo Vehicle Punctum PlugDRUG

Hydrogel punctum plug without dexamethasone

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, United States

Outcomes

Primary Outcomes

Absence of Cells in Anterior Chamber of Study Eye

Time frame: Day 8

Absence of Pain in the Study Eye

Time frame: Day 8

Data from ClinicalTrials.gov

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