EYEFILL® C. -US Viscoelastic Clinical Investigation

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02024711
Collaborator
Bausch & Lomb Incorporated (Industry)
262
Enrollment
8
Locations
2
Arms
12.5
Duration (Months)
32.8
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: EYEFILL® C.-US Viscoelastic
  • Device: Healon® Viscoelastic (CONTROL)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
262 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Dec 17, 2014
Actual Study Completion Date :
Dec 17, 2014

Arms and Interventions

ArmIntervention/Treatment
Experimental: EYEFILL® C.-US Viscoelastic

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.

Device: EYEFILL® C.-US Viscoelastic
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.

Active Comparator: Healon® Viscoelastic (CONTROL)

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.

Device: Healon® Viscoelastic (CONTROL)
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.

Outcome Measures

Primary Outcome Measures

  1. Mean Percent Cell Change (Preservation of Endothelium) [Baseline, 3 months]

    Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.

Secondary Outcome Measures

  1. Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit [3 months]

  2. Percentage of Participants With Anterior Chamber Inflammation [3 months]

  3. Percentage of Participants With Device-related Adverse Events Any Visit [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Any race

  • Older than 21 years

  • Cataract requiring cataract extraction in at least 1 eye

  • Clear intraocular media other than cataract

  • Able to provide written informed consent

  • Able and willing to comply with required follow-up schedule

  • Competent to understand the procedure and the actions asked of him/her as a research subject

Exclusion Criteria:
  • Monocular

  • Ocular infection

  • History of glaucoma, Ocular Hypertension (IOP > 21 mmHg) likely to require IOP lowering medications, ocular condition requiring IOP lowering medication, condition preventing reliable Goldmann applanation tonometry, known steroid responder

  • Previous intraocular surgery in the operative eye

  • Previous serious corneal disease or known endothelial cell loss / damage (in operative eye)

  • History of chronic or recurrent inflammatory eye disease (in operative eye)

  • Evidence of retinal vascular disease (in operative eye)

  • Uncontrolled diabetes or proliferative diabetic retinopathy

  • Acute or chronic disease or illness that would increase the operative risk

  • Allergy to anesthetics or other postoperative medications

  • Known hypersensitivity to sodium hyaluronate or other components in viscoelastic

  • Patient in any other clinical trial within the 30 days prior to the start of the study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Barnet Dulaney Perkins Eye CenterPhoenixArizonaUnited States85016
2Shasta Eye Medical GroupReddingCaliforniaUnited States96002
3Argus Research at Cape Coral Eye CenterCape CoralFloridaUnited States33904
4Eye Centers of FloridaFort MyersFloridaUnited States33901
5Newsom Eye and Laser CenterSebringFloridaUnited States33870
6Great Lakes Eye CareSaint JosephMichiganUnited States49085
7Silverstein Eye CentersKansas CityMissouriUnited States64133
8Comprehensive Eye CareWashingtonMissouriUnited States63090

Sponsors and Collaborators

  • Bausch Health Americas, Inc.
  • Bausch & Lomb Incorporated

Investigators

  • Study Director: Donald R Sanders, MD, PhD, Center for Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02024711
Other Study ID Numbers:
  • EYE-C-7.00
First Posted:
Dec 31, 2013
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Keywords provided by Bausch Health Americas, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
Period Title: Overall Study
STARTED130132
COMPLETED129128
NOT COMPLETED14

Baseline Characteristics

Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)Total
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.Total of all reporting groups
Overall Participants130132262
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
69.4
68.7
69.0
Sex: Female, Male (Count of Participants)
Female
75
57.7%
78
59.1%
153
58.4%
Male
55
42.3%
54
40.9%
109
41.6%

Outcome Measures

1. Primary Outcome
TitleMean Percent Cell Change (Preservation of Endothelium)
DescriptionPreservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Time FrameBaseline, 3 months

Outcome Measure Data

Analysis Population Description
Participants with endothelial cell density recorded at baseline and 3 months are included in the population.
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
Measure Participants130127
Mean (Standard Deviation) [percent cell change]
-10.05
(15.06)
-10.13
(15.92)
2. Secondary Outcome
TitlePercentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Description
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
Measure Participants130132
Count of Participants [Participants]
24
18.5%
20
15.2%
3. Secondary Outcome
TitlePercentage of Participants With Anterior Chamber Inflammation
Description
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
Measure Participants130132
Day 1
2
1.5%
4
3%
Day 7
2
1.5%
3
2.3%
Day 30
4
3.1%
3
2.3%
Day 90
0
0%
0
0%
4. Secondary Outcome
TitlePercentage of Participants With Device-related Adverse Events Any Visit
Description
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
Measure Participants130132
Count of Participants [Participants]
0
0%
0
0%

Adverse Events

Time Frame3 months
Adverse Event Reporting Description Adverse events were not coded. Therefore, source vocabulary is not applicable.
Arm/Group TitleEYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Arm/Group DescriptionEYEFILL ® 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. EYEFILL® C.-US Viscoelastic: 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® 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): 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.
All Cause Mortality
EYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
EYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/130 (0.8%) 2/132 (1.5%)
Blood and lymphatic system disorders
Anemia1/130 (0.8%) 0/132 (0%)
Gastrointestinal disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to undiagnosed cancer0/130 (0%) 1/132 (0.8%)
Vascular disorders
Blood clot1/130 (0.8%) 0/132 (0%)
Hematoma1/130 (0.8%) 0/132 (0%)
Other (Not Including Serious) Adverse Events
EYEFILL® C.-US ViscoelasticHealon® Viscoelastic (CONTROL)
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total69/130 (53.1%) 72/132 (54.5%)
Eye disorders
Corneal stromal edema41/130 (31.5%) 41/132 (31.1%)
Posterior capsular opacity20/130 (15.4%) 19/132 (14.4%)
Macular degeration8/130 (6.2%) 12/132 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.

Results Point of Contact

Name/TitleStudy Director
OrganizationBausch Health
Phone
Emailsusan.harris@bauschhealth.com
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02024711
Other Study ID Numbers:
  • EYE-C-7.00
First Posted:
Dec 31, 2013
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020