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 Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product (NCT05101252), a randomized na study. The primary outcome is Binocular logMAR Visual Acuity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05101252 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 77 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Eligible subjects were habitual soft contact lens wearers. The primary outcome population is described as all randomized subjects regardless of the lens actually received, withdrawal, or protocol deviation, provided they had data at the 1-Week Follow-up Evaluation. The registry record gives an enrollment of 77, but does not report how many participants contributed data to each primary outcome assessment.
Intervention
The test lens was senofilcon A C3. Participants assigned to the test arm were to follow the TEST Lens sequence for the duration of the study. The study is described as a dispensing trial; further details of lens dispensing or use are not reported in the registry record.
Comparator
The control was Dailies Total 1 Multifocal Contact Lenses, identified in the adverse-event groups as Delefilcon A. Participants assigned to the control arm were to follow the CONTROL Lens sequence. The registry record does not report additional details about the control-lens regimen.
Primary question
The primary outcome was binocular logMAR visual acuity under high-luminance, high-contrast conditions at the 1-Week Follow-up. Distance was assessed at 4 meters, with near and intermediate assessments at 40 cm and 64 cm. The record does not provide the arm-level means, standard deviations, or a single comparison estimate, so the magnitude and precision of any difference between lenses cannot be established from the recorded information.
3. Trial Design
This was a randomized, single-masked, two-arm, parallel-group, dispensing clinical trial comparing senofilcon A C3 with Dailies Total 1 Multifocal Contact Lenses. The registry record lists an enrollment of 77 and a status of completed. It gives the start date as 2021-10-11 and the primary completion date as 2021-11-29. The trial was sponsored by Johnson & Johnson Vision Care, Inc.
In a parallel-group design, each participant is assigned to one study arm rather than crossing between both lenses as part of a crossover comparison. Randomization is intended, in general, to support a fair comparison by assigning participants without selecting a lens based on their characteristics. The record identifies random allocation, but does not report the sequence-generation method, allocation concealment, or whether randomization was stratified.
The study is described as single-masked. The registry record does not state which people were masked, how masking was maintained, or whether masking was assessed. The arm descriptions refer to participants following a test-lens or control-lens sequence for the duration of the study; additional details about the sequence and study visits are not reported.
The primary outcome was assessed at the 1-Week Follow-up Evaluation. The registry record also lists binocular distance logMAR visual acuity as a secondary outcome. It records 3 outcome measures and 5 analyses, but does not provide a complete account of how each analysis relates to the outcome measures. The study's phase is listed as NA. A protocol, detailed eligibility criteria, planned sample-size justification, and full statistical analysis plan are 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.
Overall Study
| Stage | Test (Senofilcon A C3) | Control (Delefilcon A) |
|---|---|---|
| STARTED | 37 | 37 |
| COMPLETED | 35 | 34 |
| NOT COMPLETED | 2 | 3 |
Reasons for not completing this period:
| Reason | Test (Senofilcon A C3) | Control (Delefilcon A) |
|---|---|---|
| Unsatisfactory Test Article | 1 | 0 |
| Subject Withdrawn by PI due to Non Compliance to Protocol | 0 | 1 |
| Withdrew Consent during study | 0 | 1 |
| Subject dispensed incorrect lens in 1 eye | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol, with data at the 1-Week Follow-up Evaluation.
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: All subjects dispensed a study lens with data collected at the 1-week follow-up evaluation.
| Characteristic | Unit | Test (Senofilcon A C3) | Control (Delefilcon A) | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 34 | 70 | |
| Age, Continuous | Years | 58.0 (SD 5.95) | 55.4 (SD 5.48) | 56.7 (SD 5.84) |
| Sex: Female, Male: Female | Participants | 31 | 24 | 55 |
| Sex: Female, Male: Male | Participants | 5 | 10 | 15 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Black or African American | Participants | 3 | 3 | 6 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: White | Participants | 32 | 29 | 61 |
| Region of Enrollment: United States | Participants | 36 | 34 | 70 |
6. Primary Endpoint
The registry lists the primary outcome as Binocular logMAR Visual Acuity, 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 on the logMAR scale at the 1-Week Follow-up. The record describes measurements under high luminance and high contrast. Distance acuity was assessed at 4 meters with ETDRS charts; near and intermediate acuity were assessed at 40 cm and 64 cm with reduced Guillon-Poling charts. Letter-by-letter chart readings were used to calculate a visual performance score.
As a general interpretation of this scale, logMAR values closer to zero, or below zero, indicate better visual acuity. The registry record states that a score of 0.0 is equivalent to Snellen visual acuity of 20/20. The endpoint is useful for quantifying visual performance across the specified viewing distances using a continuous scale, rather than only grouping performance into broad categories.
The registry record does not report the observed arm means or standard deviations for these assessments. It also does not provide a single contrast that combines or selects among the distance, near, and intermediate results. Therefore, the endpoint description explains what was measured, but does not establish the observed visual-acuity result or its precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a comparison of binocular logMAR visual acuity between the test and control lenses at the 1-Week Follow-up. However, it does not report the numerical primary outcome results needed to describe the direction or size of a difference. Arm-level means, standard deviations, confidence intervals, and a corresponding primary comparison are not reported in the registry record. Without those values, there is no basis for saying whether the recorded visual-acuity scores were similar or different, or how precisely a difference was estimated.
The primary outcome covers distance, near, and intermediate assessments. Those viewing conditions are related but not identical measurements. A result for one distance should not be treated as a summary of all visual performance unless the analysis specifies that interpretation. The registry record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. It therefore does not support a single overall effect statement.
In general, a mean describes the center of a continuous outcome distribution, while a standard deviation describes variation among measurements. A difference in means can describe a group contrast, but its interpretation depends on the outcome scale and the assessment conditions. A confidence interval would communicate the range of values compatible with the data and analysis assumptions; a narrower interval generally indicates greater precision. No such interval or effect estimate is reported for the primary endpoint in this record.
The enrollment of 77 is a trial-level enrollment figure, not a substitute for the number with endpoint data. The primary outcome population is described as randomized subjects with data at the 1-Week Follow-up, including regardless of actual treatment, withdrawal, or protocol deviation. The numbers contributing to the different acuity assessments are not reported in the registry record, so the amount and pattern of missing endpoint data cannot be characterized.
The posted adverse-event counts record no serious adverse events in either group among the participants listed at risk. This is a descriptive safety observation for the recorded study period and population. It does not establish the absence of other adverse events, and it does not resolve the unreported primary visual-acuity comparison.
9. Statistical Methods Explained
The registry record describes the primary outcome as the mean of a continuous measure, with standard deviation as its dispersion statistic. This identifies the type of summary planned or recorded, but it does not by itself specify the statistical test, model, or adjustment used to compare the arms. Those details are not reported in the registry record.
What does a mean and standard deviation communicate?
As a general statistical explanation, the mean gives a central summary of a set of measurements. The standard deviation describes how spread out individual measurements are around that mean. Together, they can describe the distribution within an arm, but they do not alone show the uncertainty in a difference between arms. In particular, a standard deviation is not a confidence interval for a treatment contrast.
For a continuous endpoint such as logMAR visual acuity, an analysis might compare arm means, but the registry record does not state that this was the specific inferential method used. It also does not give the arm-level summary values. Consequently, no recalculated unadjusted difference, standard error, or confidence interval can be reported from the registry information.
How should uncertainty be understood?
In general, a confidence interval is an interval estimate that conveys uncertainty about a target quantity, such as a difference between group means. It reflects both the observed data and the assumptions of the method used to construct it. It is not a range containing a known proportion of individual participants' measurements, nor does it indicate that every value in the interval is equally likely. No primary-outcome confidence interval is reported in the registry record.
A p-value is a measure defined relative to a statistical model and a null hypothesis; it is not a measure of the size or clinical importance of a difference. The registry record does not report a primary-outcome p-value or identify the test from which one might have been obtained. No conclusion about statistical significance can be drawn from the outcome description alone.
What role does the planning illustration have?
The planning assumptions described for sample-size illustrations are two-sided significance level 0.05, equal allocation between arms, and a normal approximation. The assumed effect to detect is expressed as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial was designed around those assumptions. The registry record does not report a sample-size justification from the trial's own design, nor does it provide the observed effect needed to interpret the illustrations. No planning sample-size estimate can be stated from the information recorded.
As a general matter, planning calculations depend on assumptions about the effect, variability, allocation, and analysis. If an assumed effect differs from the effect of interest, the resulting planned sample size may not address the intended question. A calculation based on an observed effect is also not a replacement for interpreting the uncertainty around the observed estimate. Here, the outcome estimates needed to assess that relationship are not reported in the registry record.
Why do the viewing conditions matter?
Distance, near, and intermediate acuity are distinct assessment conditions. In general, analyzing multiple related conditions creates several opportunities to examine outcomes. If many comparisons are considered, the chance of a false-positive finding across the set can increase unless the analysis accounts for multiplicity. The registry record lists 3 outcome measures and 5 analyses, but does not report a multiplicity adjustment, a hierarchy of tests, or which comparison was designated as the principal inferential test. Therefore, the appropriate interpretation of any individual finding cannot be determined from the available analysis description.
General statistical methods for repeated or correlated outcomes can account for the fact that measurements from the same participant may be related. The registry record does not identify whether a repeated-measures model, separate comparisons, or another approach was used. It also does not report covariate adjustment, model diagnostics, or handling of departures from model assumptions. These methods should not be presumed to have been used.
10. Multiplicity, Missing Data and Analysis Populations
The primary visual-acuity assessment includes distance, near, and intermediate conditions. The registry record also lists 3 outcome measures and 5 analyses. Considering several outcomes or assessments raises a multiplicity issue: as a general matter, conducting multiple tests can increase the chance of at least one apparently notable result when all comparisons are considered together. The record does not report a multiplicity strategy, such as a prespecified testing hierarchy or adjustment, and it does not identify a single comparison that resolves the several conditions into one overall result.
The primary outcome population is described as all randomized subjects regardless of actual treatment, subsequent withdrawal, or protocol deviation, with data at the 1-Week Follow-up Evaluation. This description indicates that inclusion in the endpoint analysis requires follow-up data. It does not explain how missing values were handled, whether any imputation was performed, or how the number of participants with data varied across assessments. These details are not reported in the registry record.
As a general principle, missing-data methods can affect an estimate when the chance of having an observed measurement is related to participant characteristics or outcomes. A complete-case analysis and an analysis using imputation can rely on different assumptions. The registry record does not identify the analysis population for each of the 5 analyses or report sensitivity analyses for missing data. It is therefore not possible to assess the robustness of the primary comparison to missingness or to establish whether all randomized participants contributed to every outcome analysis.
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 (Senofilcon A C3) | 0 | 37 | 0.0% |
| Control (Delefilcon A) | 0 | 37 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test (Senofilcon A C3) | 0 of 37 |
| Control (Delefilcon A) | 0 of 37 |
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 (Senofilcon A C3) | 0 of 37 |
| Control (Delefilcon A) | 0 of 37 |
The registry record lists 37 participants at risk for serious adverse events in the test group and 37 in the control group. It records 0 serious adverse events in each group and 0 deaths in each group. These are the serious-event counts recorded for the listed groups; the record does not identify any serious adverse-event terms.
These figures should be read as descriptive counts, not as proof that serious events cannot occur or that the lenses have equivalent safety. In general, an observed zero count is compatible with uncertainty about the underlying event rate, especially when the available observation is limited. The registry record does not provide confidence intervals for the event counts or rates, a comparative safety analysis, or additional follow-up details for interpreting the duration of risk.
The serious-event counts do not describe non-serious adverse events. Although the record includes fields for other adverse events, the available information does not report their counts. Thus, the absence of recorded serious events should not be generalized to all adverse experiences or to populations and periods beyond this trial.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, single-masked, parallel-group trial compared senofilcon A C3 with Dailies Total 1 Multifocal Contact Lenses and assessed binocular logMAR visual acuity at the 1-Week Follow-up. It also describes the measurement conditions and the population intended for the primary outcome analysis. These details define the intended comparison and help explain what the outcome represents.
The record does not report the primary outcome means, standard deviations, effect estimate, confidence interval, or p-value. It therefore does not show the size, direction, or precision of a visual-acuity difference. The study's enrollment figure cannot fill that gap, because enrollment alone does not provide outcome values or indicate how many participants had data for each assessment.
In general, a randomized comparison can help estimate differences between assigned groups, while masking can reduce some forms of influence on measurement or assessment. The record does not provide enough detail to determine who was masked or how the randomization and masking procedures were implemented. These design labels should not be treated as a substitute for the missing result and analysis details.
The recorded serious adverse-event counts are zero in both groups, with 37 at risk in each. This is limited descriptive information. It does not establish that no other adverse events occurred, does not demonstrate equivalence between lenses, and does not answer the visual-acuity question.
Accordingly, the study record describes a clinical comparison and its primary measurement, but the recorded information is insufficient to make a result-level claim about the relative visual performance of the lenses. Any interpretation should remain limited to the reported design and endpoint information.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it illustrates how a clearly named endpoint can still leave the central comparison unresolved when its numerical results are not reported. The endpoint is a continuous visual-acuity measure with specified conditions and distances, and the registry record identifies mean and standard deviation summaries. Those features describe the measurement framework, but readers also need the group estimates and an uncertainty measure to understand the result.
The several assessment conditions make the analysis question important. Distance, near, and intermediate outcomes can describe different aspects of visual performance, and a finding for one condition need not summarize the others. The record lists multiple outcome measures and analyses but does not state how multiplicity was addressed or designate one reported contrast as the overall comparison. This makes transparent reporting of the analysis plan and outcome estimates especially useful.
The study also highlights the distinction between trial enrollment and endpoint-specific information. The enrollment of 77 does not reveal how many observations were available at each assessment or how missing data were handled. Reporting those details would help readers judge the precision and applicability of the comparison.
Finally, the serious adverse-event counts are straightforward to describe, but they should not be mistaken for a comprehensive safety result. Clear separation of event counts, visual-acuity estimates, uncertainty, and analysis methods allows readers to assess each question on its own terms. In this record, the design and measurement details are available, while the primary comparative estimates and much of the analysis detail are not reported.
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 main limitation for interpreting the trial's primary question is that the registry record does not report arm-level visual-acuity results or a between-group estimate. Without those results, the direction, magnitude, and precision of the comparison cannot be assessed. The record also does not provide the standard deviations for the primary outcome, despite identifying standard deviation as the dispersion measure.
The primary outcome involves distance, near, and intermediate assessments, but the record does not identify a single summary comparison or explain how these conditions were handled together. It lists 3 outcome measures and 5 analyses without a full mapping between outcomes, analyses, and statistical tests. Multiplicity procedures and any outcome hierarchy are not reported in the registry record.
Details needed to evaluate the analysis population are also limited. The primary population is described as randomized subjects with data at follow-up, but endpoint-specific participant counts, reasons for missing data, and methods for handling missing measurements are not reported. The record does not identify whether the analyses were adjusted for baseline measures or other covariates, nor does it report sensitivity analyses or model checks.
Additional trial details are limited: the registry record does not report the randomization procedure, allocation concealment, who was masked, or how masking was maintained. It also does not report a protocol-based sample-size justification or a complete statistical analysis plan. The available serious-event information does not include non-serious adverse-event counts or comparative safety estimates. These limitations constrain interpretation of both the primary outcome and the broader safety profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product — NCT05101252.
- Registry record last updated 2023-01-10; status last verified 2022-12.
- Results first posted 2023-01-10.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, randomized, single-masked, two-arm, parallel-group dispensing trial sponsored by Johnson & Johnson Vision Care, Inc. It compares senofilcon A C3 with Dailies Total 1 Multifocal Contact Lenses in habitual soft contact lens wearers. Enrollment was 77; the study start date was 2021-10-11, and the primary completion date was 2021-11-29.
The primary outcome was binocular logMAR visual acuity at the 1-Week Follow-up, assessed at distance, near, and intermediate viewing conditions. The record identifies means and standard deviations as the summary type, but does not report the primary outcome values or a single comparative estimate. Serious adverse-event counts were 0 in each group, with 37 at risk in each group. Further information on the analysis plan, missing data, multiplicity, and non-serious adverse events is not reported in the registry record.