ReSure Sealant Pivotal Study

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Cataract Surgery Incision Leak

Treatments: Device: ReSure Sealant; Procedure: Sutures

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498224

OTX-11-002

Details and patient eligibility

About

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.

Enrollment: 488 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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488 participants in 2 patient groups

Suture

Active Comparator group

Description:

Suture application

Treatment:

Procedure: Sutures

ReSure Sealant

Experimental group

Description:

Sealant application

Treatment:

Device: ReSure Sealant