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ReSure Sealant Pivotal Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT01498224
First received: December 18, 2011
Last updated: February 8, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Cataract Surgery Incision Leak
Device: ReSure Sealant
Procedure: Sutures
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ReSure Sealant Pivotal Study

Resource links provided by NLM:


Further study details as provided by Ocular Therapeutix, Inc.:

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. [ Time Frame: Days 1-28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Foreign Body Sensation [ Time Frame: Days 1-28 ] [ Designated as safety issue: Yes ]
  • Best corrected visual acuity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Best corrected visual acuity worse than 20/40 at day 1

  • Best corrected visual acuity [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Best corrected visual acuity worse than 20/40 at 28 days


Other Outcome Measures:
  • Presence of ReSure Sealant or suture(s) [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Presence of ReSure Sealant or suture(s)at every follow-up visit

  • Presence of blue colorant in ReSure Sealant [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
    Presence of blue colorant in ReSure Sealant at every follow-up visit

  • Device ease of use [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Device ease of use during application

  • Corneal edema at 1 day [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Corneal edema at 1 day (moderate to severe stromal edema)

  • Anterior chamber inflammation [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Anterior chamber inflammation (defined as greater than or equal to grade 2+ anterior chamber cells) at day 1


Enrollment: 488
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Suture
Suture application
Procedure: Sutures
Experimental: ReSure Sealant
Sealant application
Device: ReSure Sealant
Comparison of ReSure Sealant to suture(s)

  Eligibility

Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498224

Locations
United States, Florida
Levenson Eye Associates
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
Ocular Therapeutix, Inc.
  More Information

Additional Information:
Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT01498224     History of Changes
Other Study ID Numbers: OTX-11-002 
Study First Received: December 18, 2011
Last Updated: February 8, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Data is available on FDA website for approved PMA P130004

Keywords provided by Ocular Therapeutix, Inc.:
Cataract surgery

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 26, 2016