CataractsNCT05575063

Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

A study testing Investigational Healon Endocoat in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataracts
What is being tested?: Investigational Healon Endocoat
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 8 sitesUnited States
Study dates: 8 Nov 2022to 21 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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
Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

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

Conditions: Cataracts
Being tested: Investigational Healon Endocoat, Control Healon EndoCoat
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational Healon EndocoatDevice
Ophthalmic Viscoelastic device
Control Healon EndoCoatDevice
Ophthalmic Viscoelastic device

Study groups in NCT05575063
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Investigational Healon Endocoat; Device: Control Healon EndoCoat

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3-month postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202221 Dec 2023

First posted12 Oct 2022
Study start8 Nov 2022
Primary completion21 Dec 2023
Study completion21 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05575063
Sponsor's protocol ID: VSCO-110-LOKE
Status last verified: Jun 2026
First submitted: 7 Oct 2022
Last updated: 25 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
ClinicalTrials.gov ID: NCT05575063
Acronym / sponsor ID: VSCO-110-LOKE
Conditions: Cataracts
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
Study start: 8 Nov 2022 (actual)
Primary completion: 21 Dec 2023 (actual)
Study completion: 21 Dec 2023 (actual)
First posted: 12 Oct 2022 (actual)
Results: Posted 12 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Investigational Healon EndoCoat	Experimental	Device: Investigational Healon Endocoat, Device: Control Healon EndoCoatEligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.
Control Healon EndoCoat	Active comparator	Device: Investigational Healon Endocoat, Device: Control Healon EndoCoatEligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational Healon EndocoatOphthalmic Viscoelastic device	Device	Control Healon EndoCoat, Investigational Healon EndoCoat
Control Healon EndoCoatOphthalmic Viscoelastic device	Device	Control Healon EndoCoat, Investigational Healon EndoCoat

Primary outcome

Cumulative IOP Spike Rate From Safety Endpoint
Time frame: 3-month postoperative
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.
ECC Percent Change From Effectiveness Endpoint
Time frame: 3-month postoperative
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.

Results and safety

Results posted to the registry on 12 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OVD Groups	131	130

Primary outcome: Cumulative IOP Spike Rate From Safety Endpoint

Time frame: 3-month postoperative. Number. Unit: Percentage

Measure	Investigational OVD n = 131	Control OVD n = 130
Value	7.54	7.46

Investigational OVD vs Control OVD: Not Measured: 0.08 (95% CI -5.07 to 5.23), Mixed Models Analysis

Population analysed: Percentage cumulative IOP spike rate

Primary outcome: ECC Percent Change From Effectiveness Endpoint

Time frame: 3-month postoperative. Mean (Standard Error). Unit: Percentage Change

Measure	Investigational OVD n = 130	Control OVD n = 131
Value	-9.03 (1.31)	-8.53 (1.27)

Investigational OVD vs Control OVD: Difference in Percent Change: -0.5 (95% CI -3.37 to 2.37), Mixed Models Analysis

Population analysed: ECC Change in Percentage in Negative number value

Adverse events

Time frame: 3 months postoperative follow-up. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Investigational OVD	14 of 131 (10.7%)	0 of 131 (0%)	0 of 131
Control OVD	17 of 130 (13.1%)	0 of 130 (0%)	0 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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

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Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johnson & Johnson Surgical Vision, Inc. Clinical Trial study director

Johnson & Johnson Surgical Vision, Inc.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Healon Endocoat in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative IOP Spike Rate From Safety Endpoint (time frame: 3-month postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05575063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.