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 Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes (NCT05222880), a na na study. The primary outcome is Binocular logMAR Visual Acuity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05222880 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 140 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The intended participants were eligible habitual soft contact lens wearers who were dispensed the test lens. The primary outcome population is described as all dispensed subjects, regardless of protocol deviation, with data collected at the 1-week follow-up. The registry record lists enrollment as 140. That enrollment figure should not be mistaken for the number with primary outcome data: an outcome-specific analysis count is not reported in the registry record.
Intervention
Participants received the JJVC investigational multifocal contact lens manufactured in senofilcon A C3, identified in the record as the TEST Lens. The study evaluated vision, eye health and fit acceptance. The record describes dispensing the lens for the duration of the study, but does not report the individual wearing experience or the results for those areas.
Comparator
This is a single-group, single-arm study, not a randomized comparison. No control lens or concurrent comparator group is described. Consequently, the posted design does not estimate a between-group treatment contrast. Observations after dispensing can describe outcomes in this group, but cannot by themselves separate lens-associated change from other explanations.
Primary question
The primary endpoint is binocular visual acuity on the logMAR scale under high-luminance, high-contrast conditions at 1-week follow-up. The registry record specifies a mean and standard deviation as the summary. It explains that scores closer to zero, or below zero, indicate better acuity, and that 0.0 corresponds to Snellen visual acuity of 20/20. The actual mean, standard deviation, and any uncertainty estimate are not reported in the registry record, so the direction and precision of the observed result cannot be assessed from this record.
3. Trial Design
The registry identifies NCT05222880 as a completed clinical study titled “Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes.” Its listed condition is Visual Acuity. The study began on 2022-01-06, and its primary completion date is 2022-02-28. Enrollment is listed as 140. The phase is recorded as NA.
The design is identified as single-group, with allocation recorded as NA. The intervention is a device: JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3. The arm description says eligible habitual soft contact lens wearers were given the TEST Lens for the duration of the study. Because there is only a single arm, the design does not include a concurrent untreated group or a comparison lens. It is therefore descriptive with respect to outcomes in the dispensed group, rather than a randomized estimate of relative benefit.
The record contains an inconsistency about masking. Its masking field says NONE, while the brief summary describes the trial as single-masked. The record does not explain this difference, so the masking arrangement cannot be resolved from the registry information. The brief summary also characterizes the study as a dispensing clinical trial assessing vision, eye health and fit acceptance.
The primary outcome is binocular logMAR visual acuity at 1-Week Follow-up. Listed secondary outcomes are CLUE Vision Score, CLUE Comfort Score, CLUE Handling Score, and the proportion of subjects achieving an optimal lens pair in 4 lenses or less. The record lists 8 outcome measures and 12 analyses, but does not report their full results or specify which analyses correspond to each measure. The statistical analysis plan, protocol deviations, and details of the planned measurement schedule beyond the primary timeframe 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) |
|---|---|
| STARTED | 139 |
| COMPLETED | 136 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Test (Senofilcon A C3) |
|---|---|
| Unsatisfactory Visual Response due to Test Article | 1 |
| Withdrew Consent during Study | 1 |
| COVID-19 Related | 1 |
Analysis population for the primary outcome, as defined in the registry: All dispensed subjects regardless of deviation from protocol with data collected at the 1-week follow-up.
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.
| Characteristic | Unit | Hyperopes | Myopes | Total |
|---|---|---|---|---|
| Participants analysed | 50 | 89 | 139 | |
| Age, Continuous | Years | 54.1 (SD 7.20) | 50.4 (SD 6.14) | 51.7 (SD 6.76) |
| Sex: Female, Male: Female | Participants | 45 | 66 | 111 |
| Sex: Female, Male: Male | Participants | 5 | 23 | 28 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 3 | 5 |
| Race/Ethnicity, Customized: Black or African American | Participants | 2 | 9 | 11 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: White | Participants | 44 | 75 | 119 |
| Region of Enrollment: United States | Participants | 50 | 89 | 139 |
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 is binocular visual acuity measured on a logMAR scale under high-luminance, high-contrast conditions. Distance acuity is assessed at 4 meters using ETDRS charts. Near and intermediate assessments are made at 40 cm and 64 cm using reduced Guillon-Poling charts. Letter-by-letter results are used to calculate a visual performance score for each chart read.
LogMAR provides a continuous way to represent visual acuity, which can be summarized using a mean and standard deviation. The record states that scores closer to zero, or below zero, indicate better visual acuity. It also gives a familiar reference point: a logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. These definitions help interpret the scale, but do not establish a threshold for a clinically important change; such a threshold is not reported in the registry record.
The specified timeframe is 1-Week Follow-up. The analysis population is described as all dispensed subjects, regardless of deviation from protocol, with data collected at that follow-up. The endpoint can describe the group’s measured acuity at that time. Without a reported baseline value, change estimate, or comparison group, it cannot establish how acuity changed from before dispensing or how it would compare with another lens. The endpoint’s mean, standard deviation, and uncertainty are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a continuous primary outcome and specifies how to interpret the direction of its scale. However, it does not report the observed binocular logMAR mean, standard deviation, confidence interval, or another numerical result. The study’s listed status is COMPLETED, but completion status is not itself an outcome. It does not reveal whether the measured acuity was better, worse, or similar to any reference value.
For a continuous endpoint, the mean describes the group’s average measurement, while the standard deviation describes how dispersed individual measurements are around that average. Both are needed for a basic account of the result: the mean conveys location on the scale, and the standard deviation conveys variability among measured participants. Neither statistic is reported for the primary endpoint in the registry record. The number of participants contributing primary outcome data is also not reported there, so the precision of an estimate cannot be reconstructed from the record.
A confidence interval, if reported, would describe the range of values reasonably compatible with the estimate under the statistical model used. Its width would help communicate precision. No confidence interval or model for the primary result is reported in the registry record. A p-value would address a specified statistical hypothesis, but neither a primary p-value nor the associated hypothesis is reported. It is therefore not possible to characterize the result as statistically significant or not significant from the registry information.
The study has one arm and no randomized comparator. Even if a group mean were available, a single observed mean would not measure a contrast against another lens or against no lens. A comparison with a benchmark would require a prespecified reference and an appropriate analysis; neither is described in the available record. The listed outcome scale’s reference to 0.0 and 20/20 is an interpretation of the measurement scale, not evidence that the study’s group mean reached that value.
The secondary outcomes concern vision, comfort, handling, and lens-pair selection. Their names indicate areas assessed, but their numerical results are not reported in the registry record. The record lists 8 outcome measures and 12 analyses without enough detail to identify all endpoints, analysis populations, or statistical procedures. Thus, the available information supports a description of the design and endpoint definitions, but not a conclusion about the magnitude, precision, or clinical importance of the observed outcomes.
9. Statistical Methods Explained
The registry describes the primary outcome as a mean of a continuous measure, with standard deviation as its dispersion statistic. General statistical explanation: a continuous measure can take values across a scale rather than being limited to categories. A mean offers a compact description of the center of observed values; a standard deviation describes how much those values vary around the mean. Neither statistic alone describes every feature of a distribution, and a mean can be influenced by unusually high or low observations.
What does the logMAR scale contribute?
The record defines the measurement procedures and the direction of interpretation. Binocular acuity is measured under high-luminance, high-contrast conditions. Distance testing uses ETDRS charts at 4 meters; near and intermediate testing uses reduced Guillon-Poling charts at 40 cm and 64 cm. Letter-by-letter scoring produces a visual performance score for each chart read. As stated in the record, values closer to zero or below zero indicate better acuity, and 0.0 is equivalent to Snellen visual acuity of 20/20. These details make the endpoint interpretable, but do not provide an observed score or a threshold for an important difference.
How should precision be understood?
General statistical explanation: an estimate based on a sample is subject to sampling variability. A confidence interval expresses uncertainty around an estimate under the assumptions of its analysis; a narrower interval generally indicates greater precision than a wider interval. Precision depends on factors such as the amount of observed variability and the number of observations used, as well as the analysis method. The registry record does not report a confidence interval, an outcome-specific analysis count, or the primary endpoint’s observed variability. Therefore, the precision of the primary estimate cannot be evaluated from the record.
A standard deviation and a standard error are not interchangeable. The standard deviation describes variation among measurements; the standard error describes uncertainty in an estimated quantity, such as a mean. The primary endpoint definition names the standard deviation, but does not report it. No standard error is reported either. A reader should not infer precision merely from the enrollment figure, because the number enrolled need not equal the number with observed data at the primary follow-up.
What can a single-group analysis establish?
The design is identified as single-group and single-arm, with allocation recorded as NA. General statistical explanation: a single-group summary describes outcomes observed among participants in that group. It does not create a randomized counterfactual showing what would have happened to the same participants under a different lens or no lens. Without a concurrent comparator, a difference from a prior measurement, if one were reported, could also reflect factors other than the intervention. The record does not report a baseline primary endpoint result or a change analysis, so even a before-and-after comparison cannot be evaluated.
The primary analysis population is described as all dispensed subjects regardless of protocol deviation, with data collected at the 1-week follow-up. That description indicates that protocol deviation alone does not exclude a subject from the stated population. It does not specify how missing follow-up measurements are treated, whether all dispensed subjects had measurements, or whether any sensitivity analyses were conducted. Those details are not reported in the registry record.
What do the planning assumptions mean?
The record describes sample-size calculations as planning illustrations based on the observed effect, not as the trial’s own design. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Those are assumptions for hypothetical planning, not evidence that the clinical study itself used a two-arm design. The actual trial is recorded as single-group and single-arm.
General statistical explanation: a significance level sets a threshold used in a specified hypothesis-testing procedure, while a normal approximation uses properties of the normal distribution to estimate quantities such as sample-size requirements. Equal allocation is an assumption about how participants would be split between two hypothetical arms. These choices do not establish that the corresponding trial was conducted, nor do they show the probability that the observed study result was correct. Sample-size estimates are planning illustrations, not observed power. The record does not report a protocol sample-size justification, and the hypothetical planning assumptions should not be read as the protocol’s design.
The calculations are described as based on an observed effect, but the primary effect and the numerical planning estimates are not reported in the registry record. The effect fraction used for each illustration and any calculated group size therefore cannot be assessed from the registry information alone. Since a single-group study is not a like-for-like comparison of two arms, these hypothetical two-arm assumptions do not convert its results into a comparative treatment estimate.
Why does over-dispersion matter in general?
General statistical explanation: over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates may be too small and its intervals too narrow. The issue is relevant in analyses of counts or proportions when the chosen model’s variance assumptions do not fit the data. The primary endpoint is described as a continuous mean with standard deviation, and the registry record does not specify an over-dispersion model or report enough results to assess one. No conclusion about over-dispersion should be drawn from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 8 outcome measures and 12 analyses. It names four secondary outcomes: CLUE Vision Score, CLUE Comfort Score, CLUE Handling Score, and the proportion of subjects achieving an optimal lens pair in 4 lenses or less. It does not report the complete set of outcome definitions or explain how the listed analyses relate to the outcomes. A multiplicity adjustment, hierarchy of endpoints, or other approach to handling repeated statistical tests is not reported in the registry record.
General statistical explanation: when several outcomes or analyses are examined, the chance of at least one apparently unusual result can increase if each is interpreted as an independent test without an appropriate plan. Prespecifying a primary endpoint and a testing strategy can help readers distinguish the main question from exploratory analyses. The record identifies a primary outcome, but does not describe a multiplicity strategy or provide numerical analysis results to interpret.
The primary population is defined as all dispensed subjects regardless of protocol deviation, with data collected at the 1-week follow-up. This definition does not state how missing measurements were handled. Missing-data methods, the amount of missing primary outcome data, reasons for missingness, and sensitivity analyses are not reported in the registry record. Enrollment is listed as 140, but the number with primary endpoint data is not reported; the enrollment figure cannot substitute for an analysis denominator.
The adverse-event record lists 139 subjects at risk in the test group, while the study enrollment is listed as 140. These are different reported quantities for different purposes. The reason for the difference is not reported in the registry record, and it should not be inferred. The record does not provide enough information to determine whether every enrolled or dispensed subject contributed to each 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 | 139 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test (Senofilcon A C3) | 0 of 139 |
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 139 |
The safety record lists the Test (Senofilcon A C3) group with 139 subjects at risk. It records 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse event terms are listed. These figures describe what is recorded for this group in the registry record; they are not a comparison with another lens or a no-lens group.
A zero count in a registry entry does not establish that an event is impossible, nor does it establish that an intervention is free of risk. Interpretation depends on how events were defined, collected, followed, and reported. Those details, including any event-specific observation period and reporting procedures, are not reported in the registry record. The listed number at risk is a safety denominator and should not be assumed to equal the number contributing to the primary visual acuity outcome.
Because there is no comparator arm, the record cannot estimate a relative event rate between groups. It also does not provide event rates over person-time or detailed descriptions of non-serious events. The safety figures should therefore be read narrowly: the registry records no serious adverse events, no other adverse events, and no deaths for the listed test group, with 139 at risk.
12. What the Result Does, and Does Not, Mean
The record establishes the study’s setting and measurement question: a completed, single-group dispensing study of an investigational daily disposable silicone hydrogel multifocal contact lens, with binocular logMAR visual acuity at 1-Week Follow-up as the primary outcome. It specifies the testing conditions, chart methods, summary measure, and primary analysis population. These details clarify what the study intended to assess.
However, the primary mean and standard deviation are not reported in the registry record. Neither is an uncertainty interval, a p-value, or a numerical estimate of change. The listed secondary outcomes also have no numerical results in the record. As a result, the posted information does not establish the magnitude or precision of visual acuity, comfort, handling, or lens-pair selection outcomes. It also does not allow assessment of whether any observed difference would be clinically important.
The study has no randomized comparator, so it cannot provide a randomized estimate of how the test lens compares with another lens or with no lens. A single-arm result, even if reported, would describe observations in that group and would not by itself establish what would have occurred under an alternative condition. The logMAR reference to 0.0 and its equivalence to Snellen visual acuity of 20/20 helps explain the scale; it is not a reported study result or a stated success criterion.
The safety record reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 139 at risk. That is a descriptive registry entry, not proof that no events could occur or an estimate of comparative safety. The record’s completed status indicates the study’s administrative status, not whether the results met a target.
In short, the registry information supports understanding of the study design, its outcome definitions, and the recorded safety counts. It does not support a conclusion about the observed primary outcome or comparative performance. Missing result values and absent analysis details limit both statistical and clinical interpretation.
13. Why This Trial Matters Statistically
This study illustrates why a clearly defined endpoint and a reported endpoint result are both needed for statistical interpretation. The record gives a detailed description of binocular logMAR visual acuity testing, including the distances, chart types, scoring approach, timeframe, and direction of the scale. That helps readers understand what was measured. Without the observed mean and standard deviation, however, the measurement definition cannot answer what the group’s acuity was or how variable the measurements were.
The single-group design also makes the target of inference important. A descriptive summary can characterize outcomes among those measured, but a comparative question requires a comparator and an appropriate contrast. The record identifies no second arm. Planning calculations based on two-arm assumptions do not change that design; they are illustrations for hypothetical planning, not results from a comparative trial.
The record also shows the value of reporting analysis populations and missing-data procedures. The primary population is defined by dispensing and availability of data at the 1-week follow-up, while the number contributing primary measurements and the handling of missing observations are not reported. Without those details, readers cannot fully assess the basis of an estimate or its precision.
Finally, the masking information is internally inconsistent: the masking field is NONE, while the brief summary calls the study single-masked. Together with the absence of numerical outcome results and a described multiplicity plan, this limits the extent to which the record can support a reproducible statistical assessment. These are reporting limitations, distinct from any conclusion about the lens itself.
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 most consequential limitation for interpreting outcomes is that the registry record does not report numerical results for the primary endpoint. The mean, standard deviation, confidence interval, analysis count, and any test result are absent. The named secondary outcomes likewise have no reported numerical results in the available record. Accordingly, it is not possible to judge the size, variability, or precision of the observed outcomes.
The design is single-group and single-arm, with allocation recorded as NA. It offers no randomized comparator for estimating a relative outcome. The primary population is described as all dispensed subjects with data at 1-week follow-up, regardless of protocol deviation, but the number with such data and the handling of missing values are not reported. The enrollment figure of 140 does not establish the endpoint-specific analysis denominator.
The registry record reports 8 outcome measures and 12 analyses but does not detail all measures, analysis methods, or how multiplicity was handled. It also does not report a statistical analysis plan, a protocol sample-size justification, or whether any interim analyses occurred. These details should not be inferred from the planning assumptions, which describe hypothetical two-arm calculations.
There is a discrepancy in the masking description: the masking field states NONE, whereas the brief summary calls the study single-masked. The record does not explain the difference. In addition, the clinical question is limited to the recorded study setting and its 1-week primary follow-up; longer-term outcomes are not reported in the registry record. The available safety information is also limited to the listed counts and does not describe event definitions, collection methods, or duration of safety observation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes — NCT05222880.
- Registry record last updated 2023-04-13; status last verified 2023-04.
- Results first posted 2023-04-13.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05222880 is listed as COMPLETED and evaluates an investigational daily disposable silicone hydrogel multifocal contact lens manufactured in senofilcon A C3. The study is recorded as single-group and single-arm, with enrollment of 140. Its primary outcome is binocular logMAR visual acuity at 1-Week Follow-up, summarized as a mean and standard deviation among dispensed subjects with data at that time, regardless of protocol deviation.
The record names secondary outcomes concerning vision, comfort, handling, and optimal lens-pair selection. It lists 8 outcome measures and 12 analyses. The safety entry records 0 serious adverse events, 0 other adverse events, and 0 deaths among 139 at risk. Numerical results for the primary and secondary outcomes, analysis details, missing-data methods, and a multiplicity strategy are not reported in the registry record. The masking description is inconsistent between the record’s masking field and brief summary.