CompletedPhase 3

OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

438 participantsStarted 2015-10

Plain-language summary

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber 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

What they're measuring

Absence of Anterior Chamber Inflammation

Timeframe: Day 14

Absence of Ocular Pain

Timeframe: Day 8

Trial details

NCT IDNCT02736175

SponsorOcular Therapeutix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05

Results submitted2017-09-13

View on ClinicalTrials.gov More Post-Surgical Ocular Pain trials