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NCT02309736 Clinical Trial

OTX-14-002: Device Exposure Registry

Endophthalmitis Clinical Trial

Official title:
Device Exposure Registry: A Post-Approval Observational Registry of ReSure Sealant to Track the Incidence of Endophthalmitis After Sealing Corneal Incisions in Patients Undergoing Clear Corneal Cataract Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02309736
Other study ID # OTX-14-002
Secondary ID
Status Withdrawn
Phase
First received
Last updated

Study information
Verified date February 2020
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of the study is to collect post-approval data relative to the incidence of endophthalmitis for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility All patients that receive at least one application of the ReSure Sealant on the operative eye following cataract surgery will be enrolled.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ReSure Sealant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of endophthalmitis Day 30
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