EYEFILL® C. -US Viscoelastic Clinical Investigation

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

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Barnet Dulaney Perkins Eye Center	Phoenix	Arizona	United States	85016
2	Shasta Eye Medical Group	Redding	California	United States	96002
3	Argus Research at Cape Coral Eye Center	Cape Coral	Florida	United States	33904
4	Eye Centers of Florida	Fort Myers	Florida	United States	33901
5	Newsom Eye and Laser Center	Sebring	Florida	United States	33870
6	Great Lakes Eye Care	Saint Joseph	Michigan	United States	49085
7	Silverstein Eye Centers	Kansas City	Missouri	United States	64133
8	Comprehensive Eye Care	Washington	Missouri	United States	63090

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.: Cataract; Intraocular Lens; IOL; Aphakia
• Additional relevant MeSH terms: Cataract; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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
STARTED	130	132
COMPLETED	129	128
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)	Total
Arm/Group Description	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. 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 Participants	130	132	262
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

Title	Mean Percent Cell Change (Preservation of Endothelium)
Description	Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Time Frame	Baseline, 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 Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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 Participants	130	127
Mean (Standard Deviation) [percent cell change]	-10.05 (15.06)	-10.13 (15.92)

2. Secondary Outcome

Title	Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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 Participants	130	132
Count of Participants [Participants]	24 18.5%	20 15.2%

3. Secondary Outcome

Title	Percentage of Participants With Anterior Chamber Inflammation
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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 Participants	130	132
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

Title	Percentage of Participants With Device-related Adverse Events Any Visit
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EYEFILL® C.-US Viscoelastic	Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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 Participants	130	132
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Adverse events were not coded. Therefore, source vocabulary is not applicable.
Arm/Group Title	EYEFILL® C.-US Viscoelastic		Healon® Viscoelastic (CONTROL)
Arm/Group Description	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. 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 Viscoelastic		Healon® Viscoelastic (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EYEFILL® C.-US Viscoelastic		Healon® Viscoelastic (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/130 (0.8%)		2/132 (1.5%)
Blood and lymphatic system disorders
Anemia	1/130 (0.8%)		0/132 (0%)
Gastrointestinal disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to undiagnosed cancer	0/130 (0%)		1/132 (0.8%)
Vascular disorders
Blood clot	1/130 (0.8%)		0/132 (0%)
Hematoma	1/130 (0.8%)		0/132 (0%)
Other (Not Including Serious) Adverse Events
	EYEFILL® C.-US Viscoelastic		Healon® Viscoelastic (CONTROL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/130 (53.1%)		72/132 (54.5%)
Eye disorders
Corneal stromal edema	41/130 (31.5%)		41/132 (31.1%)
Posterior capsular opacity	20/130 (15.4%)		19/132 (14.4%)
Macular degeration	8/130 (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.