EYEFILL® C. -US Viscoelastic Clinical Investigation

NCT02024711 | Completed Results

• 1 other identifier: EYE-C-7.00
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 8

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.

Conditions

Cataract

Keywords

Cataract; Intraocular Lens; IOL; Aphakia

Outcome Measures

Primary Outcomes (1)

• Mean Percent Cell Change (Preservation of Endothelium)

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

  Baseline, 3 months

Secondary Outcomes (3)

• Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit

  3 months

• Percentage of Participants With Anterior Chamber Inflammation

  3 months

• Percentage of Participants With Device-related Adverse Events Any Visit

  3 months

Study Arms (2)

EYEFILL® C.-US Viscoelastic

EXPERIMENTAL

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

Healon® Viscoelastic (CONTROL)

ACTIVE COMPARATOR

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)

Interventions

EYEFILL® C.-US Viscoelastic DEVICE

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

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.

Healon® Viscoelastic (CONTROL)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (8)

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, 85016, United States

Location

Shasta Eye Medical Group

Redding, California, 96002, United States

Location

Argus Research at Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Eye Centers of Florida

Fort Myers, Florida, 33901, United States

Location

Newsom Eye and Laser Center

Sebring, Florida, 33870, United States

Location

Great Lakes Eye Care

Saint Joseph, Michigan, 49085, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

MeSH Terms

Conditions

Cataract; Aphakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

Study Officials

• Donald R Sanders, MD, PhD

  Center for Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: December 31, 2013
• Study Start: December 1, 2013
• Primary Completion: December 17, 2014
• Study Completion: December 17, 2014
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Locations

US (8)