CompletedPhase 2

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

United States60 participantsStarted 2012-10

Plain-language summary

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.

Who can participate

Age range21 Years

SexALL

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

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

What they're measuring

Absence of Cells in Anterior Chamber of Study Eye

Timeframe: Day 8

Absence of Pain in the Study Eye

Timeframe: Day 8

Trial details

NCT IDNCT01666210

SponsorOcular Therapeutix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2016-02-09

View on ClinicalTrials.gov More Ocular Inflammation and Pain trials