ReSure Sealant Pivotal Study | NCT01498224

Studies
ReSure Sealant Pivotal Study

NCT01498224

Sponsor

Ocular Therapeutix, Inc.

Status

Completed

Last Update Posted

Dec 12, 2016Estimated

Enrollment

488Actual

Phase

Phase 3

Conditions

Cataract Surgery Incision Leak

Interventions

ReSure Sealant
Sutures

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Dec 18, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2016

Last Update Posted Date

Dec 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

488Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Suture	Active Comparator	Suture application	Procedure: Sutures
ReSure Sealant	Experimental	Sealant application	Device: ReSure Sealant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ReSure Sealant	Device	Comparison of ReSure Sealant to suture(s)	ReSure Sealant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Foreign Body Sensation		Days 1-28
Best corrected visual acuity	Best corrected visual acuity worse than 20/40 at day 1	Day 1

Other Outcomes

Measure	Description	Time Frame
Presence of ReSure Sealant or suture(s)	Presence of ReSure Sealant or suture(s)at every follow-up visit	Day 28
Presence of blue colorant in ReSure Sealant	Presence of blue colorant in ReSure Sealant at every follow-up visit

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Levenson Eye Associates		Jacksonville	Florida	32204	United States

Label	URL
Publications of study results	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Data is available on FDA website for approved PMA P130004

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013537	Sutures

Ancestor Terms

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided