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ReSure Sealant, Sutures · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Suture | ACTIVE_COMPARATOR | Suture application |
| ReSure Sealant | EXPERIMENTAL | Sealant application |
| Name | Type | Description |
|---|---|---|
| ReSure Sealant | DEVICE | Comparison of ReSure Sealant to suture(s) |
| Sutures | PROCEDURE | - |
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 prese...
ReSure Sealant is a hydrogel sealant used to prevent or manage incision leaks following cataract surgery. It is applied to the corneal incision site to provide a watertight seal, reducing the risk of postoperative leakage and potential complications associated with fluid egress from the eye.
ReSure Sealant is developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OCUL. The company focuses on therapies for ophthalmic conditions, and ReSure Sealant is one of its key product candidates in the ophthalmology space.
ReSure Sealant is in Phase 3 clinical development. It has completed a pivotal Phase 3 study, and it remains an investigational product. It is not yet approved by regulatory authorities, and its safety and efficacy are still being evaluated through clinical trials.
ReSure Sealant has one completed Phase 3 clinical trial, identified as NCT01498224, titled 'ReSure Sealant Pivotal Study'. This trial enrolled 488 participants in the United States and evaluated the sealant's effectiveness in managing incision leaks during cataract surgery. The study was active-controlled and randomized.
ReSure Sealant works by forming a hydrogel barrier over the corneal incision site after cataract surgery. This sealant acts as a physical plug to prevent fluid leakage from the eye, thereby maintaining intraocular pressure and promoting proper wound healing. It is designed to be applied topically to the eye.