Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

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

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Investigational Healon Endocoat; Device: Control Healon EndoCoat

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
    • Long Beach, California, United States, 90805
      • Southern California Eye Physicians and Associates
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • Texas
    • Houston, Texas, United States, 77027
      • Berkeley Eye Institute, P.A.
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
    • San Antonio, Texas, United States, 78209
      • Focal Point Vision
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject
3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
4. 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.
5. 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)
6. 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
7. Use of systemic or ocular medications that may affect vision or IOP
8. 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
9. Poorly-controlled diabetes
10. 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.).
11. Known steroid responder
12. Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve
13. 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)
14. 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.)
15. 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
16. Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Healon EndoCoat; 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; Ophthalmic Viscoelastic device; Device: Control Healon EndoCoat; Ophthalmic Viscoelastic device
Active Comparator: Control Healon EndoCoat; 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; Ophthalmic Viscoelastic device; Device: Control Healon EndoCoat; Ophthalmic Viscoelastic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: VSCO-110-LOKE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes