ReSure Sealant Pivotal Study

December 8, 2016 updated by: Ocular Therapeutix, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Suture
Suture application
Procedure: Sutures
EXPERIMENTAL: ReSure Sealant
Sealant application
Device: ReSure Sealant
Comparison of ReSure Sealant to suture(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Days 1-28
Days 1-28

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of ReSure Sealant or suture(s)
Time Frame: Day 28
Presence of ReSure Sealant or suture(s)at every follow-up visit
Day 28
Presence of blue colorant in ReSure Sealant
Time Frame: Day 28
Presence of blue colorant in ReSure Sealant at every follow-up visit
Day 28
Device ease of use
Time Frame: Day 0
Device ease of use during application
Day 0
Corneal edema at 1 day
Time Frame: Day 1
Corneal edema at 1 day (moderate to severe stromal edema)
Day 1
Anterior chamber inflammation
Time Frame: Day 1
Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

December 18, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (ESTIMATE)

December 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-11-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available on FDA website for approved PMA P130004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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