CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 262 enrolled
Drug / intervention
EYEFILL® C.-US Viscoelastic +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02024711
NCT02024711N/ACompleted
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EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators

Bausch Health Americas, Inc.·interventional·Posted Dec 31, 2013·Updated Sep 4, 2020

In Brief

A clinical study evaluating EYEFILL® C.-US Viscoelastic and Healon® Viscoelastic (CONTROL) for Cataract. Completed, enrolled 262 participants across 8 sites.

Detailed Summary

The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery. EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery. EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
CollaboratorsBausch & Lomb Incorporated

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 31, 2013
Enrollment StartDec 1, 2013
Primary CompletionDec 17, 2014
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 12.5 years ago

Interventions

EYEFILL® C.-US Viscoelasticdevice

EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.

Healon® Viscoelastic (CONTROL)device

Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.