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

Completed · Phase 2 · Has a placebo group

Conditions studied: Ocular 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 ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Key facts

Study ID

NCT01666210

Run by

Ocular Therapeutix, Inc.

People needed

60

Starts

2012-10-01

Expected to finish

2013-08-01

Last updated by the study team

2021-10-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 at Screening
• Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface

Where it is running

• Chicago Cornea Consultants, Ltd. — Hoffman Estates, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.