Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Ocular Surgical Inflammation and Pain

In brief

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.

Key facts

Study ID

NCT02034019

Run by

Ocular Therapeutix, Inc.

People needed

247

Starts

2014-02-01

Expected to finish

2015-02-01

Last updated by the study team

2020-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texan Eye / Keystone Research, Ltd. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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