Back to resultsReSure Sealant Pivotal Study
Primary Purpose
Cataract Surgery Incision Leak
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ReSure Sealant
Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Surgery Incision Leak focused on measuring Cataract surgery
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.
Sites / Locations
- Levenson Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Suture
ReSure Sealant
Arm Description
Suture application
Sealant application
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Foreign Body Sensation
Best corrected visual acuity
Best corrected visual acuity worse than 20/40 at day 1
Best corrected visual acuity
Best corrected visual acuity worse than 20/40 at 28 days
Full Information
NCT ID
NCT01498224
First Posted
December 18, 2011
Last Updated
December 8, 2016
Sponsor
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01498224
Brief Title
ReSure Sealant Pivotal Study
Official Title
ReSure Sealant Pivotal Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery Incision Leak
Keywords
Cataract surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
488 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
Suture application
Arm Title
ReSure Sealant
Arm Type
Experimental
Arm Description
Sealant application
Intervention Type
Device
Intervention Name(s)
ReSure Sealant
Intervention Description
Comparison of ReSure Sealant to suture(s)
Intervention Type
Procedure
Intervention Name(s)
Sutures
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Foreign Body Sensation
Time Frame
Days 1-28
Title
Best corrected visual acuity
Description
Best corrected visual acuity worse than 20/40 at day 1
Time Frame
Day 1
Title
Best corrected visual acuity
Description
Best corrected visual acuity worse than 20/40 at 28 days
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
Presence of ReSure Sealant or suture(s)
Description
Presence of ReSure Sealant or suture(s)at every follow-up visit
Time Frame
Day 28
Title
Presence of blue colorant in ReSure Sealant
Description
Presence of blue colorant in ReSure Sealant at every follow-up visit
Time Frame
Day 28
Title
Device ease of use
Description
Device ease of use during application
Time Frame
Day 0
Title
Corneal edema at 1 day
Description
Corneal edema at 1 day (moderate to severe stromal edema)
Time Frame
Day 1
Title
Anterior chamber inflammation
Description
Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data is available on FDA website for approved PMA P130004
Links:
URL
http://www.resuresealant.com
Description
Publications of study results
Learn more about this trial
ReSure Sealant Pivotal Study
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