ReSure Sealant Pivotal Study

Last updated: December 8, 2016
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Completed

Phase

3

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

N/A

Clinical Study ID

NCT01498224
OTX-11-002
  • Ages > 22
  • All Genders

Study Summary

This is a randomized multicenter study to evaluate the safety and effectiveness of ReSure Sealant compared to sutures for preventing incision leakage within the first 7 days of cataract surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has a cataract and is expected to undergo clear cornea cataract surgery withphacoemulsification and implantation of posterior chamber intraocular lens

  • Subject must be 22 years of age or older

Exclusion

Exclusion Criteria:

  • Any intraocular inflammation in study eye or presence of ocular pain in operative eyeat preoperative assessment

  • Previous corneal or retinal surgery or planned multiple procedures during cataractsurgery.

Study Design

Total Participants: 488
Study Start date:
December 01, 2011
Estimated Completion Date:
November 30, 2012

Connect with a study center

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.