Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for 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 post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

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Key information

Conditions

Post Ocular Surgical Inflammation and Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Texan Eye / Keystone Research, Ltd.

Austin, Texas, 78731, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

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 in the study eye at Screening
Any intraocular inflammation in the study eye present during the screening slit lamp examination

Treatment and study plan

Dexamethasone

Drug

Punctum Plug

Drug

Primary outcomes

Absence of Cells in Anterior Chamber of the Study Eye

Time frame: Day 14
Absence of Pain in Study Eye

Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Jan 13, 2014
Registry last updated: Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed