ReSure Sealant Pivotal Study

Phase 3

Completed

• Conditions: Cataract Surgery Incision Leak
• Interventions: Procedure: Sutures; Device: ReSure Sealant

• Registration Number: NCT01498224
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-18
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• Subject has a cataract and is expected to undergo clear cornea cataract surgery with phacoemulsification and implantation of posterior chamber intraocular lens
• Subject must be 22 years of age or older

Exclusion Criteria

• Any intraocular inflammation in study eye or presence of ocular pain in operative eye at preoperative assessment
• Previous corneal or retinal surgery or planned multiple procedures during cataract surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Sutures	Suture application
ReSure Sealant	ReSure Sealant	Sealant application

Primary Outcome Measures

Name	Time	Method
Proportion of eyes with any clear corneal incision/suture leakage as determined by positive Seidel test indicating fluid egress within first 7 days after surgery.	Days 1-28

Secondary Outcome Measures

Name	Time	Method
Foreign Body Sensation	Days 1-28
Best corrected visual acuity	Day 28	Best corrected visual acuity worse than 20/40 at 28 days

Trial Locations

Locations (1)

Levenson Eye Associates; 🇺🇸 Jacksonville, Florida, United States