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ReSure Sealant Pivotal Study

NCT ID: NCT01498224

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Cataract Surgery Incision Leak

Keywords

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Cataract surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Suture

Suture application

Group Type ACTIVE_COMPARATOR

Sutures

Intervention Type PROCEDURE

ReSure Sealant

Sealant application

Group Type EXPERIMENTAL

ReSure Sealant

Intervention Type DEVICE

Comparison of ReSure Sealant to suture(s)

Interventions

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ReSure Sealant

Comparison of ReSure Sealant to suture(s)

Intervention Type DEVICE

Sutures

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Levenson Eye Associates

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.resuresealant.com

Publications of study results

Other Identifiers

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OTX-11-002

Identifier Type: -

Identifier Source: org_study_id