Trial Outcomes & Findings for Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (NCT NCT05575063)

Last Updated: 2025-12-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

165 participants

Primary outcome timeframe

3-month postoperative

Results posted on

2025-12-12

Participant Flow

A total of 165 subjects were enrolled in the study. Of these, 131 subjects (261 eyes) received the treatment and were included in the analysis.

Participant Flow table and outcome measures arms are divided by 'investigational OVD, one eye treated with investigational HEALON EndoCoat OVD' vs. 'control OVD, one eye treated with control HEALON EndoCoat OVD'.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	OVD Groups Control OVD: One eye treated with control HEALON EndoCoat OVD Investigational OVD: One eye treated with investigational HEALON EndoCoat OVD
Overall Study STARTED	131 261
Overall Study Investigational OVD	131 131
Overall Study Control OVD	130 130
Overall Study Completed Investigational OVD	131 131
Overall Study Completed Control OVD	129 129
Overall Study COMPLETED	130 260
Overall Study NOT COMPLETED	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	OVD Groups Control OVD: One eye treated with control HEALON EndoCoat OVD Investigational OVD: One eye treated with investigational HEALON EndoCoat OVD
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=131 Participants Total of 131: 129 contralaterally treated with investigational and control OVDs; 1 bilaterally treated with the investigational OVD; 1 unilaterally treated with the control OVD
Age, Customized Age Group · <60 years old	9 Participants n=26 Participants
Age, Customized Age Group · 60-69 years old	58 Participants n=26 Participants
Age, Customized Age Group · 70-79 years old	58 Participants n=26 Participants
Age, Customized Age Group · >=80 years old	6 Participants n=26 Participants
Sex: Female, Male Sex · Female	78 Participants n=26 Participants
Sex: Female, Male Sex · Male	53 Participants n=26 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	23 Participants n=26 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	108 Participants n=26 Participants
Ethnicity (NIH/OMB) Ethnicity · Unknown or Not Reported	0 Participants n=26 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=26 Participants
Race (NIH/OMB) Race · Asian	5 Participants n=26 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants
Race (NIH/OMB) Race · Black or African American	9 Participants n=26 Participants
Race (NIH/OMB) Race · White	111 Participants n=26 Participants
Race (NIH/OMB) Race · More than one race	6 Participants n=26 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=26 Participants

PRIMARY outcome

Timeframe: 3-month postoperative

Population: Percentage cumulative IOP spike rate

Outcome measures

Outcome measures
Measure	Investigational OVD n=131 Participants One eye with investigational HEALON EndoCoat OVD	Control OVD n=130 Eyes One Eye with control HEALON EndoCoat OVD
Cumulative IOP Spike Rate From Safety Endpoint	7.54 Percentage	7.46 Percentage

PRIMARY outcome

Timeframe: 3-month postoperative

Population: ECC Change in Percentage in Negative number value

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.

Outcome measures

Outcome measures
Measure	Investigational OVD n=130 Eyes One eye with investigational HEALON EndoCoat OVD	Control OVD n=131 Eyes One Eye with control HEALON EndoCoat OVD
ECC Percent Change From Effectiveness Endpoint	-9.03 Percentage Change Standard Error 1.31	-8.53 Percentage Change Standard Error 1.27

Adverse Events

Investigational OVD

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Control OVD

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational OVD n=131 participants at risk One eye treated with investigational HEALON EndoCoat OVD	Control OVD n=130 participants at risk One Eye Treated with control HEALON EndoCoat OVD
Eye disorders Increased IOP	8.4% 11/131 • Number of events 11 • 3 months postoperative follow-up There were a total of 32 AEs.	8.5% 11/130 • Number of events 11 • 3 months postoperative follow-up There were a total of 32 AEs.
Eye disorders Cystoid Macula Edema	1.5% 2/131 • Number of events 2 • 3 months postoperative follow-up There were a total of 32 AEs.	1.5% 2/130 • Number of events 2 • 3 months postoperative follow-up There were a total of 32 AEs.
Eye disorders Central Serous Retinopathy	0.76% 1/131 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.	0.77% 1/130 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.
Eye disorders Retained Lens Material	0.00% 0/131 • 3 months postoperative follow-up There were a total of 32 AEs.	0.77% 1/130 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.
Eye disorders Residual Refractive Error	0.00% 0/131 • 3 months postoperative follow-up There were a total of 32 AEs.	0.77% 1/130 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.
General disorders Hospitalization due to chest pain	0.76% 1/131 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.	0.77% 1/130 • Number of events 1 • 3 months postoperative follow-up There were a total of 32 AEs.

Other adverse events

Adverse event data not reported

Additional Information

Brian Pall, Dr.

Johnson & Johnson Surgical Vision

Phone: +1 904 6292289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER