This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2 (NCT04615507), a randomized na study. The primary outcome is Visual Performance LogMAR.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04615507 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 71 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Habitual soft contact lens wearers eligible for the trial were randomized to a lens-wear sequence. The primary-outcome population was narrower: subjects who completed all study visits without a major protocol deviation affecting a primary endpoint. The registry record reports enrollment of 71, but does not report the number in that primary-outcome population.
Intervention
The investigational lens was the JJVC Investigational Multifocal Contact Lens. The registry describes a daily disposable novel multifocal contact lens and a crossover dispensing trial.
Comparator
The control lens was the Dailies Total 1® Multifocal Contact Lens. Participants were randomized to sequences containing the Test and Control lenses.
Primary question
The primary outcome was binocular visual performance measured on the logMAR scale at distance, intermediate, and near, under high-luminance, high-contrast conditions. The registry record does not report numerical results that would show the observed performance for either lens or quantify a comparison between them.
3. Trial Design
This was a randomized, single-masked, multi-site crossover dispensing trial. The registry describes it as a 2×3 crossover and states that it involved 6 visits, with an approximate duration of 2 - 4 months. The trial was completed. The recorded start date was 2020-10-09, and primary completion was 2020-12-09. The registry lists enrollment of 71 and phase as NA.
Participants were randomized to one of two lens-wear sequences: Test/Control/Control or Control/Test/Test. Test refers to the JJVC Investigational Multifocal Contact Lens, and Control refers to Dailies Total 1® Multifocal Contact Lens. The record identifies participants as habitual soft contact lens wearers. It does not give further detail about the timing of each sequence component, any washout period, or the procedures used to maintain masking; those details are not reported in the registry record.
In general, a crossover design allows a participant to receive more than one study condition in an assigned order. This can support within-participant comparisons, but interpreting such comparisons depends on how the study handles period, sequence, and possible carryover effects. The registry record identifies the crossover structure and sequences but does not report the analysis approach for those design features. The record also does not report a sample-size justification or the planned statistical model.
The primary endpoint was assessed at a 1-Week Follow-up within each wearing period. The endpoint population was defined as subjects who completed all study visits without a major protocol deviation impacting a primary endpoint. That definition does not establish how many subjects met the criteria, and the number is not reported in the registry record.
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.
Period 1
| Stage | Test/Control/Control | Control/Test/Test |
|---|---|---|
| STARTED | 34 | 34 |
| COMPLETED | 32 | 33 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Covid-19 exposure | 2 | 1 |
Period 2
| Stage | Test/Control/Control | Control/Test/Test |
|---|---|---|
| STARTED | 32 | 33 |
| COMPLETED | 30 | 31 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Covid-19 exposure | 0 | 1 |
| Protocol Violation | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Adverse Event | 0 | 1 |
Period 3
| Stage | Test/Control/Control | Control/Test/Test |
|---|---|---|
| STARTED | 30 | 31 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 0 | 1 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Covid-19 exposure | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: All subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
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.
| Characteristic | Unit | Test/Control/Control | Control/Test/Test | Total |
|---|---|---|---|---|
| Participants analysed | 34 | 34 | 68 | |
| Age, Continuous: Age | Years | 49.0 (SD 4.72) | 52.0 (SD 7.44) | 50.5 (SD 6.36) |
| Sex: Female, Male: Sex – Female | Participants | 24 | 25 | 49 |
| Sex: Female, Male: Sex – Male | Participants | 10 | 9 | 19 |
| Race/Ethnicity, Customized: Black or African American | participants | 1 | 3 | 4 |
| Race/Ethnicity, Customized: White | participants | 33 | 31 | 64 |
| Region of Enrollment: United States | participants | 34 | 34 | 68 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Performance LogMAR, measured over 1-Week Follow-up within each wearing period.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | logMAR |
| Endpoint classification | Continuous Endpoint |
The primary endpoint, Visual Performance LogMAR, measures binocular visual performance on the logarithm of the minimum angle of resolution scale. Measurements were taken at distance (4 meters), intermediate (64 centimeters), and near (40 centimeters), using ETDRS charts under high-luminance, high-contrast lighting. Letter-by-letter results were used to calculate a visual performance score for each chart read.
The registry explains that logMAR scores closer to zero, or below zero, indicate better visual acuity; a score of 0.0 is equivalent to Snellen visual acuity of 20/20. This makes the measure a way to quantify visual performance at different viewing distances under specified test conditions. The recorded timeframe was a 1-Week Follow-up within each wearing period.
The registry also specifies a mean as the measure type and standard deviation as the dispersion measure. However, numerical means, standard deviations, or comparisons for the endpoint are not reported in the registry record. Consequently, the endpoint definition explains what was assessed, but the posted results do not establish the observed performance for either lens or the size and precision of any lens comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies visual performance as the primary outcome and describes measurements at distance, intermediate, and near. It does not report the numerical outcome values. There are therefore no posted means or standard deviations from which to describe the observed logMAR scores, and no reported estimate or confidence interval for a comparison between the investigational and control lenses. The registry record also does not report a p-value for the primary endpoint.
The outcome is described across several viewing distances and wearing periods. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. This means the available information does not support a single summary claim about overall visual performance, nor does it show whether a particular distance or period produced a different pattern. The number of outcome measures and analyses is recorded, but their numerical results and the precise comparisons represented are not given in the record.
The stated endpoint population includes participants who completed all study visits without a major protocol deviation affecting a primary endpoint. The enrollment figure alone does not indicate how many participants contributed to the primary-outcome analysis. The number meeting the endpoint-population definition and the handling of incomplete outcome measurements are not reported in the registry record.
For safety, the registry reports no serious adverse events, other adverse events, or deaths in the listed Test and Control groups. The at-risk counts are 67 for Test and 66 for Control for both serious and other adverse events. These are descriptive event counts; they do not supply numerical visual-performance results and should be interpreted separately from the efficacy endpoint.
In general, a treatment comparison is most informative when the estimate, its uncertainty, and the analysis population are reported together. Those elements are not available for the primary outcome in this registry record. The absence of numerical results does not establish that the lenses performed alike or differently; it means the magnitude and precision of any observed difference cannot be assessed from the posted results.
9. Statistical Methods Explained
The registry identifies the primary outcome as a mean of a continuous measure, with standard deviation as its dispersion measure. It does not report a specific statistical model, an estimated comparison, or an uncertainty interval for the endpoint. The methods below explain general statistical ideas relevant to interpreting this design; they do not describe unreported procedures as if they were used in this trial.
What does a mean describe?
General explanation: a mean gives a central summary of observed values. For a continuous outcome such as logMAR visual performance, a mean can summarize the scores for a group or condition. It does not describe every participant's score, and by itself it does not show how variable the individual scores are. The registry record lists a mean as the outcome parameter, but numerical means are not reported.
What does a standard deviation describe?
General explanation: a standard deviation describes the spread of measurements around their mean. A smaller standard deviation indicates that observations are more concentrated around the mean, while a larger one indicates more spread. It is not the same as the uncertainty of a group mean or of a comparison. The registry lists standard deviation as the dispersion measure but does not report its numerical value for the visual-performance outcome.
How would a comparison be interpreted?
General explanation: a comparison between lens conditions can be expressed as an estimate of how their outcome summaries differ. The estimate's direction depends on the scale and the order in which conditions are compared. For this endpoint, the registry states that scores closer to zero, or below zero, indicate better visual acuity. Without observed means or a reported comparison estimate, neither the direction nor the magnitude of a difference can be determined from this record.
A confidence interval, when reported, gives a range of values compatible with the data and the statistical method under its assumptions. Its width communicates precision: a narrower interval indicates more precision than a wider interval. A confidence interval is not reported for the primary outcome. This prevents readers from assessing how precisely any underlying comparison was estimated.
Why does the crossover structure matter?
General explanation: crossover studies assign conditions in sequence, so measurements may be related within the same participant. Statistical analyses generally need to account for that dependence rather than treating every measurement as independent. Period and sequence can also matter, and possible carryover from an earlier condition may affect later observations. The registry identifies two randomized sequences and a 2×3 crossover design, but the statistical plan and the treatment of within-participant dependence, period, sequence, and carryover are not reported in the registry record.
The endpoint was measured at a 1-Week Follow-up within each wearing period. The record does not specify which observations were included in each analysis or how repeated measurements across distances and periods were modeled. As a result, the design description alone does not reveal the exact estimand—the particular comparison the analysis was intended to estimate.
What can significance testing establish?
General explanation: a p-value, if reported, describes how compatible the observed data are with a specified null hypothesis under the assumptions of the statistical test. It does not measure the size or clinical importance of an effect, and it does not replace an estimate with an uncertainty interval. No primary-outcome p-value or test procedure is reported in the registry record. The sample-size planning assumptions list a two-sided significance level of 0.05, but those assumptions describe a planning illustration based on an observed effect, not a reported test result or a confirmed feature of the trial's own design.
That planning illustration assumes equal allocation between two arms and a normal approximation, with the effect to detect stated as a fraction of the observed effect. The record says that non-time-to-event planning figures refer to participants per arm. These are planning assumptions only; they are not observed power, and they do not provide evidence about the primary endpoint. The registry does not report the trial's own sample-size justification.
Why should analysis populations be specified?
General explanation: an analysis population defines which participants and measurements contribute to an estimate. Different inclusion rules can change both the target question and the results. The primary endpoint description specifies a population of subjects who completed all study visits without a major protocol deviation impacting a primary endpoint. The count in this population and the handling of participants who did not meet the definition are not reported in the registry record. Without those details and the outcome estimates, readers cannot judge the effects of exclusions or missing measurements.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covers distance, intermediate, and near visual performance, and is associated with follow-up within each wearing period. The registry explicitly notes that the primary outcome has several categories or time points and is not reduced to one comparison. It lists 2 outcome measures and 5 analyses, but does not give numerical results or explain how those analyses relate to the outcome categories, time points, or randomized sequences.
When multiple outcomes, time points, or comparisons are examined, multiplicity can arise: the chance of at least one apparently unusual finding may increase as more hypotheses are tested. General statistical approaches can address multiplicity by defining a primary comparison in advance or adjusting inference across a family of tests. The registry record does not report whether either approach, or another multiplicity strategy, was used. It is therefore not possible to determine how the several categories and analyses were handled in inferential reporting.
The primary-outcome population is defined by completion of all study visits without a major protocol deviation impacting a primary endpoint. The number meeting that definition is not reported. Nor are the amount and pattern of missing visual-performance data, the reasons for missingness, or the method used to handle missing observations. The registry record also does not report whether analyses were conducted in additional populations or how protocol deviations were assessed.
These omissions limit assessment of how representative the analyzed participants were of all enrolled participants and whether the reported outcomes, if available elsewhere, would be sensitive to analysis choices. They do not establish that data were missing or that a particular method was used; those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Test | 0 | 67 | 0.0% |
| Control | 0 | 66 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test | 0 of 67 |
| Control | 0 of 66 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Test | 0 of 67 |
| Control | 0 of 66 |
The registry reports zero serious adverse events in the Test group, with 67 participants at risk, and zero in the Control group, with 66 participants at risk. It also reports zero other adverse events in each group, using the same respective at-risk counts, and zero deaths in both groups. No serious adverse-event terms are listed.
These figures describe the events recorded in the registry for the listed groups. They do not provide information about visual-performance outcomes, and the event counts should not be interpreted as a comparison of lens effectiveness. A zero count means that no events of the specified kind were recorded in the reported group; it does not prove that the underlying risk is absent.
General explanation: event counts are most informative when read with the population at risk, the event definitions, the observation period, and the completeness of reporting. The registry gives at-risk counts and event counts, but further detail on event definitions, timing, severity beyond the serious-event category, or the method of safety analysis is not reported in the registry record. The listed figures should therefore be read as the registry's reported safety summary, rather than as a complete account of all possible safety evidence.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, subject-masked crossover trial compared an investigational multifocal contact lens with Dailies Total 1® Multifocal Contact Lens and assessed binocular visual performance on a logMAR scale. It defines the viewing distances, testing conditions, follow-up timeframe, and population specified for the primary endpoint. These details clarify what the outcome was intended to measure.
However, the numerical primary-outcome results are not reported in the registry record. Readers cannot determine the mean scores for either lens, the difference between conditions, the precision of an estimated comparison, or whether any formal statistical test supported a particular conclusion. The record therefore does not establish that one lens had better visual performance, that performance was equivalent, or that any difference was meaningful.
In general, a claim of similarity requires more than a lack of a reported difference: it depends on a defined comparison and sufficiently precise estimates. Likewise, a claim of a difference depends on the observed estimate and its uncertainty, not only on the study design or the existence of analyses. Neither kind of conclusion can be drawn from the endpoint information posted in this record.
The safety summary reports zero serious adverse events, zero other adverse events, and zero deaths in both listed groups. Those counts are limited to the safety information recorded and do not resolve the missing visual-performance results. The sample-size assumptions are planning illustrations based on an observed effect; they are not a substitute for the trial's outcome estimates and are not observed power.
The appropriate interpretation is therefore descriptive and limited: the registry describes the question and its measurement approach, but does not provide the numerical results needed to judge the primary comparison. Details of the statistical plan, missing-data handling, multiplicity approach, and analysis population beyond its stated eligibility definition are also not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for its crossover structure. Participants were randomized to sequences that included both the investigational and control multifocal lenses. In general, crossover designs can make within-participant comparisons relevant because outcomes from the same participant may be related. That feature also makes the analysis plan important: an analysis needs to account for the design and clarify how periods and sequences contribute to the comparison. The registry identifies the design and sequences, but does not report those analytical details.
The endpoint is also measured across distinct viewing distances and wearing periods. Distance, intermediate, and near performance may represent different aspects of visual function, so retaining the separate outcome categories can be informative. At the same time, multiple categories and analyses raise questions about which comparisons were primary and how multiplicity was addressed. The record acknowledges that the outcome was not reduced to one comparison, but does not describe the inferential strategy.
The trial record offers a clear operational definition of the endpoint, including the logMAR scale, chart method, lighting conditions, and assessment timing. These details help readers understand what was measured. Yet a detailed measurement description cannot substitute for estimates, measures of uncertainty, and a transparent account of the analysis population. Those numerical results and methods are not reported in the registry record.
For statistical interpretation, the key lesson is to distinguish a well-defined question from a reported answer. The registry makes the intended comparison and outcome recognizable, but the posted information does not quantify the primary result. The event counts offer a separate safety summary, not a basis for inferring visual performance. The record is therefore useful for understanding the trial's design and endpoint, while its results cannot support a numerical assessment of the lens comparison.
14. 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 principal limitation for interpreting the primary endpoint is that numerical visual-performance results are not reported in the registry record. There are no posted means, standard deviations, comparison estimates, confidence intervals, or primary-outcome p-values. Without these values, the direction, magnitude, and precision of the observed comparison cannot be assessed.
The outcome spans distance, intermediate, and near measurements and is assessed within each wearing period. The record notes that the outcome has several categories or time points and is not reduced to one comparison. It does not identify the principal contrast among these measurements or describe how multiplicity was handled. The registry lists 5 analyses, but does not explain their precise purpose or report their results.
Although the trial is described as a 2×3 crossover with two randomized sequences, the statistical model and handling of within-participant dependence, period, sequence, or carryover are not reported in the registry record. These omissions make it difficult to assess whether the analytic approach reflected the design.
The primary-outcome population is defined as participants completing all study visits without a major protocol deviation impacting a primary endpoint, but its size is not reported. Missing-data amounts, reasons, and handling are not reported either. Consequently, the contribution of exclusions or incomplete observations cannot be evaluated.
The safety information is limited to group at-risk counts and recorded event counts; additional details about definitions, timing, and safety-analysis procedures are not reported. Finally, the sample-size information is explicitly a planning illustration based on the observed effect, rather than the trial's own design justification. It should not be treated as a report of observed power or as a replacement for the missing endpoint estimates.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population; Part 2 — NCT04615507.
- Registry record last updated 2022-04-01; status last verified 2022-03.
- Results first posted 2022-04-01.
- 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.
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18. Record Summary
NCT04615507 is a completed, randomized, single-masked, multi-site crossover dispensing trial of a JJVC Investigational Multifocal Contact Lens and Dailies Total 1® Multifocal Contact Lens in habitual soft contact lens wearers. The record describes a 2×3 crossover, 6 visits, and an approximate duration of 2 - 4 months. Enrollment was 71.
The primary outcome was binocular Visual Performance LogMAR at distance, intermediate, and near, assessed at a 1-Week Follow-up within each wearing period. Numerical primary-outcome results and the statistical analysis details are not reported in the registry record. Safety summaries list zero serious adverse events, zero other adverse events, and zero deaths in both groups.