Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

NCT05575063 | Completed Results FDA Device

• 1 other identifier: VSCO-110-LOKE
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 8

Brief Summary

Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (2)

• Cumulative IOP Spike Rate From Safety Endpoint

  The cumulative IOP spike rate is the proportion of eyes that experienced at least one IOP spike within each arm during the 3-month postoperative period. The status of the cumulative IOP spike is either 'Yes, Spike' or 'No, Non-Spike,' and the results of the cumulative IOP spike rate are presented in percentage. For this outcome measure, subjects have been analyzed as per treated received, which gives investigational OVD of 131 participants and 131 eyes treated; and control OVD of 130 participants and 130 eyes treated.

  3-month postoperative

• ECC Percent Change From Effectiveness Endpoint

  The success criterion for the primary effectiveness endpoint was met (modified ITT Population) as the investigational device (HEALON EndoCoat OVD) demonstrated non-inferiority to the control device (HEALON EndoCoat OVD) with respect to the difference in mean ECC percent change. For this outcome measure, subjects have been analyzed as per planned randomization schema, which gives investigational OVD of 130 participants and 130 eyes randomized; and control OVD of 131 participants and 131 eyes randomized.

  3-month postoperative

Study Arms (2)

Investigational Healon EndoCoat

EXPERIMENTAL

Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.

Device: Investigational Healon Endocoat; Device: Control Healon EndoCoat

Control Healon EndoCoat

ACTIVE COMPARATOR

Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.

Device: Investigational Healon Endocoat; Device: Control Healon EndoCoat

Interventions

Investigational Healon Endocoat DEVICE

Ophthalmic Viscoelastic device

Control Healon EndoCoat; Investigational Healon EndoCoat

Control Healon EndoCoat DEVICE

Ophthalmic Viscoelastic device

Control Healon EndoCoat; Investigational Healon EndoCoat

Eligibility Criteria

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

You may qualify if:

• Minimum 22 years of age
• Cataracts for which extraction and posterior chamber IOL implantation have been planned in both eyes
• Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization

You may not qualify if:

• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
• Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
• Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision or IOP
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study, or in the opinion of the investigator, may confound the outcome(s) of the study
• Poorly-controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).
• Known steroid responder
• Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
• Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the average of the three cell counts as taken by the Konan Specular Microscope)
• Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (8)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Southern California Eye Physicians and Associates

Long Beach, California, 90805, United States

Location

Scott & Christie and Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Berkeley Eye Institute, P.A.

Houston, Texas, 77027, United States

Location

Focal Point Vision

San Antonio, Texas, 78209, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Brian Pall, Dr.
• Organization: Johnson & Johnson Surgical Vision

bpall@its.jnj.com

+1 904 6292289

Study Officials

• Johnson & Johnson Surgical Vision, Inc. Clinical Trial

  Johnson & Johnson Surgical Vision, Inc.

  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: October 7, 2022
• First Posted: October 12, 2022
• Study Start: November 8, 2022
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (8)