Trial Outcomes & Findings for EYEFILL® C. -US Viscoelastic Clinical Investigation (NCT NCT02024711)

NCT ID: NCT02024711

Last Updated: 2020-09-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 262 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2020-09-04

Participant Flow

Participant milestones

Measure	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. 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® 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. 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.
Overall Study STARTED	130	132
Overall Study COMPLETED	129	128
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EYEFILL® C. -US Viscoelastic Clinical Investigation

Baseline characteristics by cohort

Measure	EYEFILL® C.-US Viscoelastic n=130 Participants 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® Viscoelastic (CONTROL) n=132 Participants 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 n=262 Participants Total of all reporting groups
Age, Continuous	69.4 years n=93 Participants	68.7 years n=4 Participants	69.0 years n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	78 Participants n=4 Participants	153 Participants n=27 Participants
Sex: Female, Male Male	55 Participants n=93 Participants	54 Participants n=4 Participants	109 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Participants with endothelial cell density recorded at baseline and 3 months are included in the population.

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

Outcome measures

Measure	EYEFILL® C.-US Viscoelastic n=130 Participants 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® Viscoelastic (CONTROL) n=127 Participants 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.
Mean Percent Cell Change (Preservation of Endothelium)	-10.05 percent cell change Standard Deviation 15.06	-10.13 percent cell change Standard Deviation 15.92

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	EYEFILL® C.-US Viscoelastic n=130 Participants 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® Viscoelastic (CONTROL) n=132 Participants 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.
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit	24 Participants	20 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	EYEFILL® C.-US Viscoelastic n=130 Participants 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® Viscoelastic (CONTROL) n=132 Participants 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.
Percentage of Participants With Anterior Chamber Inflammation Day 1	2 Participants	4 Participants
Percentage of Participants With Anterior Chamber Inflammation Day 7	2 Participants	3 Participants
Percentage of Participants With Anterior Chamber Inflammation Day 30	4 Participants	3 Participants
Percentage of Participants With Anterior Chamber Inflammation Day 90	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	EYEFILL® C.-US Viscoelastic n=130 Participants 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® Viscoelastic (CONTROL) n=132 Participants 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.
Percentage of Participants With Device-related Adverse Events Any Visit	0 Participants	0 Participants

Adverse Events

EYEFILL® C.-US Viscoelastic

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

Healon® Viscoelastic (CONTROL)

Serious events: 2 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	EYEFILL® C.-US Viscoelastic n=130 participants at risk 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® Viscoelastic (CONTROL) n=132 participants at risk 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.
Gastrointestinal disorders Total colon blockage	0.00% 0/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	0.76% 1/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to undiagnosed cancer	0.00% 0/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	0.76% 1/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Vascular disorders Blood clot	0.77% 1/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	0.00% 0/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Vascular disorders Hematoma	0.77% 1/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	0.00% 0/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Blood and lymphatic system disorders Anemia	0.77% 1/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	0.00% 0/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.

Other adverse events

Measure	EYEFILL® C.-US Viscoelastic n=130 participants at risk 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® Viscoelastic (CONTROL) n=132 participants at risk 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.
Eye disorders Corneal stromal edema	31.5% 41/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	31.1% 41/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Eye disorders Posterior capsular opacity	15.4% 20/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	14.4% 19/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.
Eye disorders Macular degeration	6.2% 8/130 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.	9.1% 12/132 • 3 months Adverse events were not coded. Therefore, source vocabulary is not applicable.

Additional Information

Study Director

Bausch Health

Email: susan.harris@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER