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 Hyperopic Population (NCT04567186), a randomized na study. The primary outcome is Binocular Visual Acuity (logMAR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04567186 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 81 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The trial title identifies a hyperopic population. The registry describes eligible participants as habitual soft contact lens wearers. The primary-outcome population is more specifically described as participants who completed all study visits without a major protocol deviation affecting a primary or secondary endpoint. The record does not give further demographic or clinical details about this population.
Intervention
The test device was the investigational senofilcon A C3 Multifocal Lens. Participants were randomized to a lens-wear sequence, rather than to a single parallel treatment group. The record describes sequences containing test and control lens wear.
Comparator
The control device was the delefilcon A Multifocal Lens. The registry describes two sequences: Test/Control/Control and Control/Test/Test. It does not provide additional details about the timing or conditions of each lens-wear period.
Primary question
The primary outcome was binocular visual acuity, measured on the logMAR scale at distance, intermediate and near. The record does not report numerical outcome estimates or a single test-versus-control comparison across these categories. It therefore does not establish from the posted primary results how the lenses compared at any of the measured distances.
3. Trial Design
This was a randomized, single-masked, crossover dispensing trial. The registry describes it as a multi-site, 2×3 crossover study with 6 visits and an approximate duration of 2 - 4 months. The masking description identifies the study as single-masked, and the brief summary specifies that participants were subject-masked. The record does not describe masking of other study personnel.
Eligible participants were habitual soft contact lens wearers and were randomized to one of two lens-wear sequences: Test/Control/Control or Control/Test/Test. Test refers to the investigational senofilcon A C3 Multifocal Lens, and Control refers to the delefilcon A Multifocal Lens. A crossover design exposes participants to more than one treatment condition over the course of a study. The sequences indicate that both test and control lens wear were included, but the registry record does not report the period schedule, any washout arrangements, or details about how sequence effects were handled.
The registry reports enrollment of 81 and a completed study status. The recorded study dates are 2020-09-06 for the start and 2020-11-25 for primary completion. These dates and the completion status describe the study record; they do not supply the missing primary-outcome estimates.
The primary outcome was binocular visual acuity at the 1-Week Follow-up, evaluated at distance, intermediate and near. Subjective Overall Vision Scores were listed as a secondary outcome. The record identifies two outcome measures and five analyses, but does not include a single numerical primary comparison in the information available for interpretation.
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 | 38 | 40 |
| COMPLETED | 37 | 37 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| COVID-19 related | 1 | 0 |
| Protocol Violation | 0 | 1 |
| Adverse Event | 0 | 2 |
Period 2
| Stage | Test/Control/Control | Control/Test/Test |
|---|---|---|
| STARTED | 37 | 37 |
| COMPLETED | 37 | 34 |
| NOT COMPLETED | 0 | 3 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| COVID-19 Related | 0 | 1 |
| Protocol Violation | 0 | 1 |
| Lost to Follow-up | 0 | 1 |
Period 3
| Stage | Test/Control/Control | Control/Test/Test |
|---|---|---|
| STARTED | 37 | 34 |
| COMPLETED | 36 | 34 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Subject no longer meets eligibilty criteria | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Subjects that completed all study visits without a major protocol deviation impacting a primary or secondary 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 | All Dispensed Subjects |
|---|---|---|
| Participants analysed | 78 | |
| Age, Continuous | Years | 56.6 (SD 6.84) |
| Sex: Female, Male: Female | Participants | 61 |
| Sex: Female, Male: Male | Participants | 17 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 |
| Race/Ethnicity, Customized: Asian | Participants | 5 |
| Race/Ethnicity, Customized: Black or African American | Participants | 7 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 1 |
| Race/Ethnicity, Customized: White | Participants | 63 |
| Race/Ethnicity, Customized: Other | Participants | 2 |
| Region of Enrollment: United States | Participants | 78 |
6. Primary Endpoint
The registry lists the primary outcome as Binocular Visual Acuity (logMAR), measured over 1-Week Follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | logMAR |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was binocular visual acuity measured in logMAR at the 1-Week Follow-up. It was assessed at distance (4 meters), intermediate (64 cm) and near (40 cm), under high-luminance, high-contrast conditions using ETDRS charts. The registry describes letter-by-letter scoring and specifies the lighting and chart-luminance conditions used for assessment.
LogMAR is a scale for recording visual acuity. In this scale, scores closer to zero, or below zero, indicate better visual acuity. The registry notes that a logMAR score of 0.0 is equivalent to Snellen visual acuity of 20/20. This direction matters when interpreting a comparison: a lower logMAR mean corresponds to better measured acuity, while the clinical interpretation still depends on the size and precision of the difference between conditions.
Measuring more than one viewing distance can characterize visual performance across different tasks, rather than relying on a single distance. However, the record does not report the separate means, standard deviations, or lens comparisons for distance, intermediate and near. It therefore does not support a numerical conclusion about any one distance or an overall summary across them.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies binocular visual acuity as the primary outcome and gives the scale, assessment distances, measurement conditions and target follow-up. It does not report numerical means, standard deviations, confidence intervals, or test-versus-control estimates for the primary outcome. In addition, the primary outcome has several categories or time points and is not reduced to one comparison. As a result, no single numerical primary-outcome result can be interpreted from the record.
This absence is important for statistical interpretation. A comparison of lens conditions would ordinarily be described using the estimated difference in mean acuity, together with a measure of uncertainty such as a confidence interval. A confidence interval indicates a range of values compatible with the observed data under the statistical model. Its width helps show how precisely the effect has been estimated. Neither an effect estimate nor a confidence interval for the primary outcome is reported in the registry record.
The scale's direction is documented: logMAR scores closer to zero, or below zero, indicate better acuity. That definition explains how a reported mean would be read, but it does not reveal which lens had a better observed mean. The record also does not report p-values for the primary outcome. Therefore, it is not possible to assess statistical evidence for a lens comparison, or to distinguish a small estimated difference from a larger one.
The study used a crossover structure, with randomized sequences that included both test and control lens wear. In general, crossover data can allow comparisons that account for measurements made under different conditions within the same participant. The statistical interpretation depends on the analysis model and on how the design's sequence and period structure are handled. The registry record does not report the primary analysis model or its treatment of those design features, so these should not be inferred.
There is a separate safety record: no serious adverse events and no other adverse events are listed for the reported Test and Control groups. These counts describe the posted safety entries, not the visual-acuity outcome. They do not fill the gap in the primary efficacy results, and they do not establish the absence of all possible harms. The record's primary-outcome data are insufficient to quantify precision or compare the lenses statistically.
9. Statistical Methods Explained
What does a mean describe?
The primary outcome is classified as a continuous measure summarized by a mean. A mean is a measure of the central level of a set of observations. It can be useful when the numerical scale has meaningful increments and the average level is of interest. For a treatment comparison, the mean in each condition and the estimated contrast between conditions help describe the observed pattern. In this record, the primary outcome's mean and standard deviation are identified as the intended summary, but numerical values for them are not reported in the registry record.
A standard deviation describes how spread out observations are around their mean. It is not the same as the uncertainty in the mean or in a treatment contrast. Uncertainty also depends on the amount of information and on the analysis design. Since the record does not report primary-outcome standard deviations, means or contrast estimates, the spread and precision of the visual-acuity results cannot be assessed.
How should logMAR be read?
The registry states that logMAR scores closer to zero, or below zero, indicate better visual acuity, and that 0.0 corresponds to Snellen visual acuity of 20/20. This is a general interpretation guide for the scale. When comparing means, the direction of the numerical contrast must be matched to the order of the lens conditions; the sign alone is not meaningful without knowing which condition is subtracted from which. The record does not give a contrast or state a contrast direction, so no treatment effect can be reconstructed.
What does a confidence interval contribute?
In general, a confidence interval expresses uncertainty around an estimate. It helps readers judge which effect sizes are reasonably compatible with the data and analysis, rather than relying only on a point estimate. A narrow interval indicates greater precision than a wide interval, while an interval spanning values in different directions can leave the direction of an effect uncertain. This general explanation does not imply that any interval was reported for this trial: no primary-outcome interval appears in the registry record.
Why does the crossover structure matter?
In general, a crossover study assigns participants to sequences of treatment conditions, allowing observations from different conditions to be collected over time. A statistical model may account for the fact that multiple observations from one participant are related, rather than treating every observation as independent. Depending on the design and analysis, period and sequence effects may also be relevant. The registry describes randomized Test/Control/Control and Control/Test/Test sequences, but does not report the model, the handling of period or sequence, or any other primary-outcome analysis details. These methods cannot be assumed from the design label alone.
More generally, within-participant comparisons can be influenced by changes over time or by effects carried from one period into another. Design details and the analysis plan help readers assess whether such issues were considered. The registry record does not report washout arrangements or explain how possible carryover was addressed. This is a limit on what can be evaluated from the record, not evidence that a particular design problem occurred.
What can planning calculations say?
The registry's stated planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are planning assumptions, not a report of the trial's original design rationale. The record does not report the trial's own sample-size justification.
Planning sample sizes are hypothetical illustrations for a future study under specified assumptions; they are not observed power and do not change the uncertainty of the results already collected. In this case, the primary outcome is not reduced to one comparison, and the numerical observed effect needed to interpret an effect-based illustration is not reported in the registry record. No planning sample-size figure should therefore be treated as evidence about the trial's observed outcome or its design adequacy.
What analysis details are absent?
The registry record does not report the primary statistical model, a contrast estimate, confidence interval, p-value, or a detailed statistical plan. It also does not explain how multiple outcome categories were handled in inference. The randomized crossover design and the measurement description provide context, but do not substitute for those analysis details. General statistical principles can clarify what such information would mean; they cannot recover an unreported analysis or result.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes visual-acuity assessments at distance, intermediate and near. The registry record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. When several outcomes or comparisons are examined, multiplicity can arise: the more statistical tests considered, the greater the chance that at least one result appears noteworthy by chance alone. In general, a statistical plan may define a primary contrast, use an adjustment, or treat analyses as descriptive. The registry record does not report which approach, if any, was used for these outcomes.
The record lists Subjective Overall Vision Scores as a secondary outcome, and identifies two outcome measures and five analyses. It does not provide a complete account of how those analyses relate to each other, whether they were prespecified, or whether multiplicity was addressed. No particular adjustment or hierarchy should be inferred.
The analysis population for the primary endpoint is described as participants who completed all study visits without a major protocol deviation impacting a primary or secondary endpoint. The record does not report the number included in that population, how many participants had missing endpoint measurements, or how missing observations were handled. It also does not report whether an intention-to-treat or other analysis population was used for the primary comparison.
In general, missing data can affect both the estimated treatment effect and its precision, especially when the reasons for missingness are related to outcomes or treatment conditions. The appropriate interpretation depends on the extent and pattern of missingness and on the methods used to address it. Since those details are not reported in the registry record, the potential impact of missing data cannot be evaluated.
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 | 75 | 0.0% |
| Control | 0 | 77 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test | 0 of 75 |
| Control | 0 of 77 |
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 75 |
| Control | 0 of 77 |
The registry lists no serious adverse events in the Test group among 75 participants at risk and no serious adverse events in the Control group among 77 participants at risk. It also lists no other adverse events in the Test group among 75 at risk and none in the Control group among 77 at risk. No top serious-event terms are listed.
These figures describe the adverse-event entries in the registry. They are not estimates of visual acuity and do not provide a statistical comparison of the primary outcome. The at-risk counts are reported separately for the Test and Control groups; the crossover design means these entries should not be read as independent parallel groups or added to create a total participant count.
Zero events recorded in these categories means that none were listed for the specified groups in the registry record. It does not prove that the risk of an event is zero, nor does it rule out events that were not captured or reported. The record does not provide further safety-analysis details, event definitions, or a broader account of safety monitoring. The reported counts should therefore be read as a limited description of the posted safety data, not as proof of overall safety.
12. What the Result Does, and Does Not, Mean
The registry describes a randomized, subject-masked crossover study of two multifocal contact lenses in a hyperopic population, with binocular visual acuity measured at distance, intermediate and near. The record specifies how acuity was scored and how to interpret the direction of the logMAR scale. It also records no serious or other adverse events in the listed Test and Control groups.
Those details do not establish which lens had better measured acuity. Numerical primary-outcome means, standard deviations, treatment contrasts and confidence intervals are not reported in the registry record. The outcome spans several distances and is not reduced to one comparison. Without estimates and uncertainty, the size, direction and precision of any difference cannot be assessed from the posted primary results.
In general, a statistically significant result would not by itself establish that a difference is important to patients, and a non-significant result would not establish that treatments are equivalent. Such conclusions require the estimates, uncertainty, design and an appropriate interpretation of clinical relevance. The record does not report an equivalence or non-inferiority margin, and no such conclusion should be inferred.
The safety counts likewise have a limited meaning. They report no events in the categories listed, but are not proof that no adverse events could occur. Overall, the registry record provides useful information about the design, endpoint definition and recorded safety counts, while leaving the central numerical comparison of visual acuity unreported. The appropriate conclusion is that the primary treatment comparison cannot be quantified from the reported information.
13. Why This Trial Matters Statistically
This trial illustrates why a clearly defined endpoint and a reported treatment estimate are both needed for statistical interpretation. The registry gives a detailed description of binocular visual acuity measurement, including the logMAR scale, the viewing distances, the chart method and the assessment conditions. That information explains what the outcome represents and how its direction should be read.
The study's crossover design also makes analysis details especially relevant. In general, observations collected under more than one treatment condition within participants may be related, and time or sequence can matter. Knowing that participants were randomized to lens-wear sequences is useful, but a design label alone does not disclose how the data were modeled or how uncertainty was calculated.
The record also demonstrates a distinction between an endpoint being named and a result being interpretable. It identifies multiple acuity categories and reports the intended mean and standard-deviation summaries, yet does not provide numerical primary-outcome estimates or one consolidated comparison. Without those results, readers cannot assess effect size or precision, even when the measurement protocol is described.
Finally, recorded zero adverse events and completed study status answer different questions from the primary efficacy endpoint. Keeping outcome definitions, analysis methods, uncertainty and safety reporting distinct helps prevent a registry description from being mistaken for a complete statistical account of a trial.
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 this trial is that the registry record does not report numerical primary-outcome results. It gives no means, standard deviations, treatment contrasts, confidence intervals or p-values for binocular visual acuity. Since the endpoint includes distance, intermediate and near assessments and is not reduced to one comparison, the primary treatment effect cannot be quantified or its precision judged.
The primary-outcome population is described in terms of study completion and the absence of a major protocol deviation affecting an endpoint, but the record does not report how many participants met that definition or how many were excluded. Missing measurements and the methods used to handle them are not reported. The record also does not give the primary analysis model or explain how the crossover sequences and repeated measurements were handled.
The registry describes a subject-masked, multi-site, 2×3 crossover dispensing trial, but does not report the period schedule, washout arrangements, or the handling of possible period or carryover effects. It does not report a multiplicity strategy for the outcome categories and analyses. These omissions limit assessment of the statistical plan; they do not establish that any particular analysis or design issue occurred.
The posted safety counts are limited to the listed adverse-event categories and at-risk groups. They do not establish the absence of all possible harms. Finally, the registered planning assumptions are not the trial's own sample-size justification, which is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population — NCT04567186.
- Registry record last updated 2022-01-21; status last verified 2021-12.
- Results first posted 2022-01-21.
- 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
The registry record describes NCT04567186, Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population. It was a randomized, single-masked, multi-site crossover dispensing trial, described as 2×3 with 6 visits. The sequences were Test/Control/Control and Control/Test/Test. Enrollment was 81, and the status is completed.
The test lens was the investigational senofilcon A C3 Multifocal Lens; the control was the delefilcon A Multifocal Lens. The primary outcome was binocular visual acuity in logMAR at the 1-Week Follow-up, assessed at distance, intermediate and near. Subjective Overall Vision Scores were listed as a secondary outcome.
The registry reports no serious or other adverse events in the listed Test and Control groups. Numerical primary-outcome estimates and a single primary comparison are not reported in the registry record, limiting statistical interpretation of the lens comparison.