Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (NCT05575063), a randomized na study. The primary outcome is Cumulative IOP Spike Rate From Safety Endpoint.

2. Clinical Question

The endpoint is an eye-level event rate: an eye was classified as having a spike if it experienced at least one IOP spike during the specified period. The registry record reports rates of 7.54% for investigational OVD and 7.46% for control OVD. It also reports a mixed-model analysis with an estimate of 0.08 and a 95% confidence interval from -5.07 to 5.23. The record identifies the analysis as a noninferiority analysis, but does not report the noninferiority margin. Therefore, the rate estimates and their uncertainty can be described, but the decision criterion for noninferiority cannot be assessed from the registry record alone.

The comparison concerns the two OVDs within the paired-eye design. It is not a comparison of two separate groups of participants, and the arm-specific participant counts should not be added to infer a total number of unique people in the primary analysis. The registry record does not report further details about eligibility criteria or the clinical definition used to identify an IOP spike.

3. Trial Design

The investigation is listed as randomized, double-masked, and parallel, and its brief summary describes it as prospective, multicenter, paired-eye, and subject/evaluator-masked. Each eligible subject was to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in the fellow eye. This arrangement permits a within-subject comparison: each participant contributes an eye to each treatment condition, so the two eye outcomes from the same person may be related.

The registry record lists cataracts as the condition, Johnson & Johnson Surgical Vision, Inc. as sponsor, and the study status as completed. The start date is 2022-11-08 and the primary completion date is 2023-12-21. The phase is listed as NA. Enrollment is recorded as 165. The primary-outcome description states that the treated-as-received analysis included 131 participants and 131 eyes in the investigational arm and 130 participants and 130 eyes in the control arm. Those arm-specific counts describe the analysis population for the outcome, not necessarily all enrolled participants.

The outcome was assessed over the 3-month postoperative period. The registry record lists two outcome measures and two analyses, but does not provide further details about the second outcome or analysis in the registry record for this account. No additional information about randomization sequence generation, allocation concealment, treatment administration, masking procedures, or follow-up beyond the stated endpoint timeframe is reported in the registry record.

The paired-eye feature matters for interpreting the comparison. Outcomes within a person may share characteristics, so an analysis that accounts for the relationship between the fellow eyes may be more appropriate than treating every eye as independent. The registry identifies the reported comparison method as Mixed Models Analysis, but does not describe the model specification, covariates, correlation structure, or handling of any departures from the paired-eye design.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 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'.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Percentage cumulative IOP spike rate

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Of the 131 treated subjects, data from 100% (131 /131) of the eyes treated with the investigational OVD and 99.2% (129/130) of the eyes treated with the control OVD were available at the final 3-month visit.

6. Primary Endpoint

The registry lists the primary outcome as Cumulative IOP Spike Rate From Safety Endpoint, measured over 3-month postoperative.

The primary endpoint is the cumulative IOP spike rate: the proportion of eyes in each arm that experienced at least one IOP spike during the 3-month postoperative period. The endpoint classifies each eye as either having a spike or not having a spike, then reports the arm-level result as a percentage. It captures whether an eye had any qualifying event over the defined period; it does not describe the number of spikes per eye, their timing, duration, severity, or clinical consequences.

A cumulative event rate is useful when the question concerns whether an event occurred at least once during a specified follow-up window. It reduces repeated events in the same eye to a yes-or-no outcome for that period. The resulting proportion is straightforward to describe, but it does not retain distinctions between an eye with one event and an eye with multiple events.

The registry reports a rate of 7.54% for investigational OVD and 7.46% for control OVD. The analysis population is stated as treated as received, with 131 participants and 131 eyes in the investigational arm and 130 participants and 130 eyes in the control arm. The record does not report the detailed event ascertainment rules or any additional endpoint definitions. Accordingly, interpretation is limited to the cumulative occurrence measure as defined in the registry record, rather than to broader measures of pressure change or eye health.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a binary eye-level outcome summarized as a percentage. An eye counts as having the event if at least one IOP spike occurred during the 3-month postoperative period; otherwise, it is classified as a non-spike eye. The reported arm percentages are 7.54% for investigational OVD and 7.46% for control OVD. This type of endpoint summarizes occurrence over a fixed period, rather than the event count, time to first event, or size of any pressure change.

What does the mixed-model analysis contribute?

The registry identifies Mixed Models Analysis as the method for the two-arm comparison. In general, mixed models can represent dependence among observations, including measurements or outcomes that share a participant. That feature is relevant in a paired-eye study, where the two eyes from one subject may have related outcomes. Modeling that relationship can affect the estimated comparison and its uncertainty.

The method name does not reveal the exact analysis. The registry record does not report the model formula, the response distribution or link, any covariates, the correlation structure, or the precise way the paired-eye design entered the model. It also does not state whether any adjustments beyond the pairing were used. These details are necessary to reproduce the analysis and to judge whether the model’s assumptions fit the endpoint and design. The reported result should therefore be read as the registry’s mixed-model estimate, not as a model that can be reconstructed from the record.

How should the confidence interval be read?

The registry reports an estimate of 0.08 and a 95% confidence interval from -5.07 to 5.23. A confidence interval expresses the uncertainty around an estimate under the analysis method and its assumptions. In repeated applications of the same method under its conditions, intervals constructed in this way would cover the target parameter at the stated rate. It does not mean there is a 95% probability that this particular interval contains the true effect.

The interval reaches both negative and positive values. The registry does not provide a p-value for the analysis. The estimate and interval are sufficient to describe the reported comparison and its precision, but not to decide a noninferiority claim without the margin. The margin specifies the largest difference that would be accepted for that purpose. Since no margin is reported, the analysis objective cannot be evaluated against its criterion from these data alone.

Why does pairing matter?

In an unpaired design, the two treatment groups consist of different participants. In this investigation, each subject was assigned both treatments, one in each eye. The treatment comparison can therefore use the within-subject pairing, while allowing for the possibility that fellow-eye outcomes are associated. Treating all eyes as independent would disregard that feature. The registry’s method label suggests a model-based comparison, but the record does not detail the model’s treatment of dependence, so the exact role of pairing cannot be confirmed from the registry record.

The arm counts are 131 participants and 131 eyes for investigational OVD and 130 participants and 130 eyes for control OVD. The counts apply to the treated-as-received endpoint analysis. Because participants contribute eyes in both arms, arm counts should not be interpreted as separate, non-overlapping samples. The registry does not report whether the same subjects contributed to both analyzed arms in every case or how partial paired data, if any, were handled.

What does the endpoint omit?

A cumulative rate collapses each eye’s event history into whether at least one spike occurred during the period. It does not distinguish an isolated event from repeated events, and it does not describe when a spike happened or its magnitude. A comparison of these rates therefore addresses event occurrence as defined by the study, not all dimensions of IOP or safety. The registry description does not provide the event threshold, assessment schedule, adjudication process, or rules for handling events with uncertain timing.

The primary outcome has a stated timeframe of 3-month postoperative. The record does not describe follow-up completeness at that endpoint, missing outcome handling, imputation, or sensitivity analyses. It also does not report the protocol’s statistical analysis plan or sample-size justification. These items should not be inferred from the use of a mixed model or from the enrollment figure.

How should planning illustrations be understood?

Any sample-size illustration based on an observed effect is a planning exercise, not an account of the trial’s achieved power. Such an illustration depends on assumptions about the target effect, significance level, allocation, and statistical approximation. It does not replace the trial’s actual design justification, which is not reported in the registry record. The registry record does not report the trial’s own sample-size justification, interim analyses, or detailed statistical plan.

In general, over-dispersion occurs when observed variability exceeds what a simple model assumes. It can make standard errors and confidence intervals too small if not accommodated. The endpoint is a binary eye-level rate and the trial has a paired-eye structure, but the registry does not report an over-dispersion assessment or model diagnostics. It is therefore not possible to say whether over-dispersion was present or how it was addressed.

10. Analyses Reported by the Sponsor

The registry reports the sponsor’s comparison as a Mixed Models Analysis, with an estimate of 0.08 and a 95% confidence interval from -5.07 to 5.23. The analysis is classified as noninferiority. No separate recalculated estimate from posted summary statistics is reported in the registry record, so there is no independent simple comparison to set alongside the sponsor’s model-based result.

The arm rates, 7.54% for investigational OVD and 7.46% for control OVD, are descriptive summaries. They do not reproduce the mixed-model analysis, which may account for the paired-eye design and other model features not specified in the record. A direct recalculation from the displayed percentages would not necessarily match the sponsor’s model-based estimate or confidence interval.

The noninferiority margin is not reported in the registry record. As a result, the estimate and interval can be described but cannot be judged against the study’s noninferiority threshold. The registry record also does not provide enough model detail to independently reproduce the sponsor’s analysis. The interpretation should remain anchored to the reported mixed-model estimate and its stated interval, with those limitations made explicit.

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists two outcome measures and two analyses, but the additional outcome and analysis details are not reported in the registry record. No secondary outcomes are posted in the registry record for this account. The record does not describe a strategy for controlling multiplicity across outcomes, analyses, time points, or other comparisons. It is therefore not possible to determine whether any multiplicity adjustment was planned or applied, or whether the primary endpoint was tested within a broader family of hypotheses.

The registry record does not report interim analyses, early stopping rules, or a statistical analysis plan. It also does not report the noninferiority margin. These omissions matter because a noninferiority analysis depends on a prespecified threshold, while interpretation across multiple outcomes can depend on how the analysis plan handled repeated testing. No conclusions about those procedures should be inferred from the study’s randomized design or from the reported model label.

The primary endpoint description states that subjects were analyzed as treated received. It lists 131 participants and 131 eyes in the investigational arm and 130 participants and 130 eyes in the control arm. This identifies the analysis population used for the posted endpoint, but it does not explain how treatment deviations were defined, whether all randomized subjects were included, or how the analysis relates to an intention-to-treat population. Those details are not reported in the registry record.

Missing outcome data, incomplete follow-up, and imputation are also not described. The record does not state how an eye with unavailable endpoint status was handled, whether any observations were excluded, or whether sensitivity analyses assessed the effect of missingness. The enrollment figure of 165 and the arm-specific analyzed counts do not establish why those counts differ. The reasons and any resulting potential for bias are not reported in the registry record.

These gaps constrain assessment of the reported result. Without the analysis plan, missing-data methods, multiplicity approach, and noninferiority margin, a reader cannot fully evaluate how the result was selected, whether all intended analyses are represented, or whether the formal decision rule was satisfied. The available result remains interpretable as the posted model-based comparison for the stated endpoint and analysis population, but not as a complete account of all prespecified statistical procedures.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: increased iop (8.5%), cystoid macula edema (1.5%), central serous retinopathy (0.8%), retained lens material (0.8%), residual refractive error (0.8%).

The registry lists serious adverse events affecting 14 of 131 participants in the investigational OVD group and 17 of 130 participants in the control OVD group. It reports zero other adverse events in each arm and zero deaths in each arm. These are arm-specific counts as recorded, not a complete description of the type, timing, duration, or outcome of every event.

The serious-event terms listed include Increased IOP at 8.5%, Cystoid Macula Edema at 1.5%, Central Serous Retinopathy at 0.8%, Retained Lens Material at 0.8%, Residual Refractive Error at 0.8%, and Hospitalization due to chest pain at 0.8%. The record does not identify the treatment arm for each listed term in the information, so the terms should not be attributed to one arm. Nor should the term percentages be converted into event counts without additional information about their denominators and counting rules.

Serious adverse-event counts are descriptive safety information. They do not establish that an OVD caused an event, and the listed counts alone do not support a causal comparison. The registry does not report event-level details or a statistical comparison of these safety results. Interpretation is therefore limited to the counts and terms as recorded.

13. What the Result Does, and Does Not, Mean

The posted results show similar arm-level cumulative IOP spike rates: 7.54% for investigational OVD and 7.46% for control OVD over the 3-month postoperative period. The sponsor’s mixed-model comparison estimate is 0.08, with a 95% confidence interval from -5.07 to 5.23. Those figures describe the recorded endpoint and its model-based uncertainty; they do not establish the result for outcomes that were not reported.

The record identifies the comparison as a noninferiority analysis, but does not report the noninferiority margin. A noninferiority conclusion requires judging the confidence interval against that threshold. Since the threshold is absent, the formal noninferiority conclusion cannot be independently evaluated from the registry record. Similar percentages are not, by themselves, proof of equivalence or noninferiority.

The result also does not establish that the treatments are identical. A confidence interval contains uncertainty, and this interval extends across values on both sides of zero. It does not rule out all potentially meaningful differences. Whether any value within the interval would be considered acceptable depends on a clinical and statistical margin that is not reported.

The endpoint concerns whether an eye experienced at least one spike during the specified period. It does not indicate how many spikes occurred, when they occurred, how large they were, or what consequences followed. Nor does it answer questions about other safety outcomes, longer follow-up, or outcomes beyond the primary endpoint. While serious adverse-event counts are reported, the record does not supply enough event-level information for causal attribution or a detailed comparison.

Finally, the analysis reflects the treated-as-received population described for this outcome, not necessarily every enrolled or randomized subject. The registry does not explain the difference between total enrollment and analyzed arm counts, or report missing-data methods and the complete analysis plan. The most defensible interpretation is therefore limited: the registry posts the stated arm rates and a mixed-model estimate with its confidence interval, while key information needed to assess the noninferiority decision and fully audit the analysis is not reported in the registry record.

14. Why This Trial Matters Statistically

This investigation is statistically notable for its paired-eye design. Each subject was assigned investigational OVD in one eye and control OVD in the fellow eye, allowing the treatment comparison to be made within subjects. Paired designs can account for characteristics shared by both eyes and may provide a different comparison from a trial assigning separate participants to each treatment. They also require analysis that respects the relationship between fellow eyes.

The registry labels the primary comparison as Mixed Models Analysis, a method that can accommodate related observations when its structure is specified appropriately. However, the model details are not reported in the registry record. That makes this a useful example of the distinction between a method label and a reproducible statistical analysis: the former identifies a broad approach, while the latter requires details about the model and the data it used.

The endpoint is also an instructive example of a cumulative binary outcome. It answers whether at least one qualifying event occurred during a defined period, but omits event frequency and severity. The posted percentages are easy to describe, yet the noninferiority interpretation depends on a margin that is not reported. Thus, closely neighboring point estimates are not enough to determine the conclusion of a noninferiority study.

The results illustrate why uncertainty and analysis details matter alongside arm-level rates. The confidence interval extends from -5.07 to 5.23 around the reported estimate of 0.08. Without the noninferiority margin and model specification, readers can describe the estimate and its uncertainty but cannot fully assess the decision rule or reproduce the analysis. The record also leaves missing-data, multiplicity, and sample-size justification details unreported.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record gives limited detail about the analysis beyond naming Mixed Models Analysis. It does not report the model formula, distributional assumptions, link function, correlation structure, covariates, diagnostics, or the specific method used to account for pairing. Those details are important for understanding and reproducing a model-based comparison in a paired-eye study.

The noninferiority margin is not reported. Consequently, the result cannot be evaluated against the study’s formal noninferiority criterion from the registry record alone. The record also does not report the statistical analysis plan, sample-size justification, interim analyses, or whether multiplicity was addressed across the two listed outcome measures and analyses.

The registry states that the endpoint analysis was treated as received and reports 131 participants and 131 eyes in the investigational arm and 130 participants and 130 eyes in the control arm. It does not explain how those counts relate to the enrollment of 165, identify reasons for exclusions or unavailable outcomes, or describe an intention-to-treat analysis. Missing outcome handling, imputation, and sensitivity analyses are not reported.

Endpoint details are also limited. The record defines the measure as at least one IOP spike during the 3-month postoperative period, but does not report the spike threshold, assessment schedule, adjudication process, event timing, or severity. The cumulative rate does not capture recurrent events or distinguish their consequences. Further details about the other listed outcome measure and analysis are not reported in the registry record.

The safety information is presented as serious adverse-event counts and selected terms, without event-level descriptions or an analysis comparing arms. The arm attribution of the listed serious-event terms is not stated in the available record. These reporting limits mean the figures should be treated as descriptive and should not be used to infer causation. Overall, the available record supports a focused reading of the primary endpoint and reported comparison, but not a full audit of the trial’s statistical or safety procedures.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) — NCT05575063.
• Registry record last updated 2026-06-25; status last verified 2026-06.
• Results first posted 2025-12-12.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed, randomized, double-masked, prospective, multicenter, paired-eye investigation of investigational versus control Healon EndoCoat OVD in subjects with cataracts. Each subject was assigned investigational OVD in one eye and control OVD in the fellow eye. Enrollment is listed as 165.

The primary endpoint was the cumulative IOP spike rate during the 3-month postoperative period. The treated-as-received analysis included 131 participants and 131 eyes for investigational OVD and 130 participants and 130 eyes for control OVD. The reported rates were 7.54% and 7.46%, respectively. The mixed-model analysis estimate was 0.08, with a 95% confidence interval from -5.07 to 5.23, and was classified as noninferiority.

The noninferiority margin, detailed model specification, missing-data methods, multiplicity strategy, and sample-size justification are not reported in the registry record. Serious adverse-event counts were 14 of 131 in the investigational arm and 17 of 130 in the control arm; no other adverse events or deaths were recorded in either arm.