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 the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses (NCT06377488), a na na study. The primary outcome is HLHC Binocular logMAR Visual Acuities.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06377488 |
| Phase | NA |
| Condition | Visual Acuity |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 176 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Eligible habitual soft contact lens wearers who were dispensed the test lens. The primary outcome population includes all dispensed subjects with data collected at the 2-week follow-up, regardless of protocol deviation.
Intervention
A daily disposable multifocal toric contact lens made from Senofilcon A (C3) material with a UV blocker and HEV filter. Participants wore the test lens in both eyes, for a minimum of 6 hours a day, every day, between visits.
Comparator
There is no separate comparator group. The registry describes a single-group study in which eligible subjects were fit with the test lens. A like-for-like control comparison is therefore not part of the recorded design.
Primary question
What binocular visual acuity was measured under high luminance, high contrast conditions at the 2-week follow-up among dispensed subjects with outcome data? The registry specifies the measure and assessment conditions, but the numerical outcome results are not reported in the registry record.
The study is registered as NCT06377488 and is titled Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses. Its stated focus is visual acuity. Secondary outcomes include CLUE Vision, Comfort, and Handling Scores, as well as the proportion of subjects achieving an optimal lens pair in 4 lenses or less. Numerical results for these outcomes are not reported in the registry record.
This question is descriptive rather than a comparison of assigned treatments: the record identifies only a test arm and lists allocation as NA. The design can describe measurements obtained after fitting the test lens, but it does not define a concurrent control group against which to estimate a treatment contrast. Whether participants had other relevant characteristics or whether results were assessed in subgroups is not reported in the registry record.
3. Trial Design
This is a completed, open-label, single-group device study of a daily disposable silicone hydrogel multifocal toric contact lens. The registry lists the study as completed, with 176 participants enrolled. The recorded start date is 2024-04-22, and the primary completion date is 2024-06-24. The phase is listed as NA, which is consistent with the record presenting this as a device evaluation rather than a phase-designated drug trial.
The brief summary describes an open-label, 3-visit, single-arm dispensing trial to evaluate visual acuity. Eligible subjects were habitual soft contact lens wearers and were fit with the test lens in both eyes. They were to wear it for a minimum of 6 hours a day, every day, between visits for approximately 2 weeks. The primary outcome timeframe is the 2-week follow-up. Details about the exact visit schedule, procedures at each visit, and permitted changes in lens use are not reported in the registry record.
Open-label means masking is recorded as none; participants and study personnel were not described as masked. The record identifies no randomized allocation and no separate control arm. Consequently, observations are within a single group and cannot, by themselves, separate changes associated with lens use from other influences such as measurement variation, expectations, or changes over time. This is a design limitation for causal interpretation, not evidence that any particular influence occurred.
Johnson & Johnson Vision Care, Inc. is listed as sponsor. The registry identifies a device intervention manufactured in Senofilcon A (C3) material with a UV blocker and HEV filter. The registry record does not report a protocol rationale for the chosen enrollment, a sample-size justification, or a prespecified statistical analysis plan. The enrollment figure should therefore be read as the recorded number enrolled, not as evidence that a particular precision or power target was achieved.
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 | 171 |
| COMPLETED | 163 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | Test (Senofilcon A C3) |
|---|---|
| Unsatisfactory Visual Response due to Test Article | 2 |
| Unsatisfactory Lens Fitting due to Test Article | 2 |
| Protocol Violation | 1 |
| Lost to Follow-up | 1 |
| Incorrect Lens Dispensed | 2 |
Analysis population for the primary outcome, as defined in the registry: All dispensed subjects regardless of deviation from protocol with data collected at the 2-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 | Myopes | Hyperopes | Total |
|---|---|---|---|---|
| Participants analysed | 105 | 66 | 171 | |
| Age, Continuous | Years | 49.9 (SD 6.89) | 59.1 (SD 6.10) | 53.5 (SD 7.97) |
| Sex: Female, Male: Female | Participants | 68 | 51 | 119 |
| Sex: Female, Male: Male | Participants | 37 | 15 | 52 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 9 | 3 | 12 |
| Race (NIH/OMB): White | Participants | 93 | 62 | 155 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | Participants | 105 | 66 | 171 |
6. Primary Endpoint
The registry lists the primary outcome as HLHC Binocular logMAR Visual Acuities, measured over 2-Week Follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | logMAR |
| Endpoint classification | Continuous Endpoint |
The primary outcome is binocular visual acuity measured on the logMAR scale under high luminance, high contrast conditions at the 2-week follow-up. Distance acuity was assessed at 4 meters using ETDRS charts. Near and intermediate acuity were assessed at 40 cm and 64 cm, respectively, using reduced Guillon-Poling charts. Letter-by-letter results were used to calculate a visual performance score for each chart read.
LogMAR expresses visual acuity on a scale where scores closer to zero, or below zero, indicate better acuity. A score of 0.0 is equivalent to Snellen visual acuity of 20/20. In general, a standardized acuity measure makes it possible to describe performance consistently across assessments and to summarize results using a mean and standard deviation. The registry specifies the primary outcome parameter as a mean and its dispersion as a standard deviation.
The stated analysis population includes all dispensed subjects, regardless of deviation from protocol, with data collected at the 2-week follow-up. Hyperopes and myopes were combined for this outcome because the registry states that their logMAR scores are similar. The record does not report the mean, standard deviation, number contributing data, or any interval estimate for the primary outcome. Thus, the endpoint definition and measurement approach are described, but the observed visual acuity cannot be characterized numerically from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a primary visual-acuity endpoint but does not report its numerical results. It gives no mean logMAR score, standard deviation, analysis sample size, confidence interval, or test result for binocular acuity at the 2-week follow-up. As a result, the size and precision of the observed acuity measurements cannot be evaluated from the registry record. The outcome definition alone does not establish what values participants achieved.
The direction of the scale is important for any eventual reading of numerical results: scores closer to zero, or below zero, indicate better visual acuity, and 0.0 is equivalent to Snellen 20/20. The record combines hyperopes and myopes for this endpoint, stating that their logMAR scores are similar. It does not give separate numerical results for either group, so subgroup patterns cannot be assessed.
The study enrolled 176 participants, but enrollment is not the same as the number included in an outcome analysis. The primary population is defined as all dispensed subjects with data at the 2-week follow-up, regardless of protocol deviation. The number who were dispensed lenses, completed follow-up, or contributed outcome data is not reported in the registry record. Therefore, the enrollment total does not establish completeness of follow-up or the amount of missing endpoint data.
The study has no recorded comparator arm and is not randomized. Even if numerical pre-to-post or follow-up measurements were available, a single-group design would not provide a concurrent comparison that controls for influences unrelated to the test lens. The record does not describe a baseline-to-follow-up contrast as the primary analysis; it defines the outcome at the 2-week follow-up. Details of any additional change analysis are not reported in the registry record.
There are 10 outcome measures and 16 analyses recorded, but the registry does not give numerical results or identify how these analyses relate to one another. The statistical analysis plan, handling of multiple outcomes, and any prespecified hierarchy are not reported in the registry record. In general, evaluating many outcomes or analyses can make isolated findings harder to interpret unless the analysis plan explains how multiplicity is addressed. No conclusion about statistical significance or clinical importance can be drawn from the outcome descriptions alone.
The safety entry lists 171 subjects at risk in the test group, with 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the recorded event counts; they do not resolve the missing efficacy results, and they should not be interpreted as proof that an event is impossible. Overall, the record supplies study design and endpoint definitions, but not the numerical primary outcome evidence needed to quantify the observed acuity or its precision.
9. Statistical Methods Explained
The endpoint is described as a mean of a continuous measure. In general, a continuous outcome can take values across a scale rather than belonging to a small set of categories. A mean describes the central location of observed measurements, while a standard deviation describes how spread out those measurements are around the mean. These summaries answer different questions: the mean describes the average observed score, and the standard deviation describes variation among measurements. Neither summary is reported numerically for the primary endpoint in the registry record.
What does the logMAR scale communicate?
The registry defines logMAR as Logarithm of Minimal Angle of Resolution and specifies that lower scores, closer to zero or below zero, indicate better visual acuity. It also states that a logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. These details give the direction and one reference point for interpreting an eventual score. They do not substitute for the observed mean or show how individual participants performed. Because the score is continuous, a group mean can summarize performance while concealing the range or distribution of participant-level measurements.
In general, a confidence interval is a way to express the statistical precision of an estimate. It gives a range of values compatible with the data and a specified interval procedure, under its assumptions. A narrow interval indicates greater precision than a wide interval, but the interval does not by itself establish clinical importance or eliminate bias. No confidence interval for the primary outcome is reported in the registry record, so its precision cannot be assessed using that method.
Why does the analysis population matter?
The primary outcome population is defined as all dispensed subjects regardless of deviation from protocol, provided they had data collected at the 2-week follow-up. This definition includes participants with protocol deviations if their endpoint data were collected, but it does not include people without that outcome observation. In general, an analysis population determines which participants contribute to a summary and can affect both the estimate and its precision. The number with follow-up data, the number excluded from the endpoint analysis, and the reasons for any exclusions are not reported in the registry record.
Missing outcome data can matter because participants with recorded measurements may differ from participants without them. General statistical approaches include describing the amount and pattern of missingness, making assumptions about unobserved values, and conducting sensitivity analyses to test how conclusions change under alternative assumptions. The registry record does not report the amount or pattern of missing primary outcome data, imputation procedures, or sensitivity analyses. It is therefore not possible to determine how missingness was addressed.
How should single-group evidence be read?
This is a single-group, open-label design with no recorded randomized comparator. In general, a mean at follow-up describes the participants who were measured; it does not by itself estimate a difference from another treatment or from an untreated condition. Without a concurrent comparator, variation over time, measurement conditions, expectations, and other factors cannot be distinguished from effects associated with the intervention through a controlled contrast. This is a limitation of the design's inferential scope, not a claim that any specific factor changed the measurements.
Masking is listed as none. In general, unmasked measurement can be more susceptible to observer or participant expectations when outcomes involve judgment or participant reporting. The primary endpoint is described as chart-based visual acuity with letter-by-letter scoring, but the record does not report masking of assessors, procedures for standardizing testing, or checks on measurement reliability. It is not possible to determine from the registry record whether these safeguards were used.
What do the analysis counts and planning assumptions establish?
The record lists 10 outcome measures and 16 analyses, but does not identify a full statistical plan, the methods for estimating uncertainty, or which analyses were prespecified. In general, a prespecified plan helps distinguish planned analyses from exploratory ones and clarifies how outcomes, populations, and missing data are handled. The registry does not report whether interim analyses occurred or how multiplicity was addressed.
A separate sample-size planning illustration is described as based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is explicitly not the trial's own design. In general, such a calculation explores hypothetical sample sizes for a specified comparison and effect; it is not observed power and does not change the fact that this study is single-group. No numerical planning results are stated in the registry record, and the trial's sample-size justification is not reported in the registry record. The assumptions in that illustration should not be taken as the trial's analysis plan.
These distinctions matter because design, analysis, and reporting each constrain what can be inferred. A clearly defined outcome tells readers what was intended to be measured. A reported estimate and uncertainty would show the observed data and their precision. A documented analysis plan would clarify how the estimate was produced. Here, the registry describes the measure and population, but the numerical endpoint results and detailed statistical methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 10 outcome measures and 16 analyses. It identifies several secondary outcomes: CLUE Vision Scores, CLUE Comfort Scores, CLUE Handling Scores, and the proportion of subjects achieving an optimal lens pair in 4 lenses or less. However, the registry record does not report how the analyses map to these outcomes, which analyses were prespecified, or whether a hierarchy was used.
In general, multiplicity arises when several outcomes, comparisons, or analyses are examined. The more findings considered, the more important it is to understand whether the analysis plan controlled the interpretation of multiple statistical tests or distinguished confirmatory from exploratory analyses. The registry record does not report a multiplicity adjustment or another strategy for addressing this issue. No numerical outcome results are available in the record to assess in any case.
The primary population includes all dispensed subjects with 2-week follow-up data, regardless of protocol deviation. The number with data, the number without data, and the reasons for missing measurements are not reported in the registry record. The registry also does not report whether missing values were imputed, whether complete-case analysis was used, or whether sensitivity analyses were conducted. In general, missing-data methods depend on assumptions about why observations are absent; without the missingness information and analysis details, their impact cannot be evaluated.
The record does not report interim analyses or a detailed statistical analysis plan. It also does not explain whether any outcome or analysis was added or changed during the study. These omissions limit assessment of how the listed outcomes and analyses were selected and interpreted.
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 | 171 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test (Senofilcon A C3) | 0 of 171 |
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 171 |
The registry lists 171 subjects at risk in the Test (Senofilcon A C3) group. It records 0 subjects affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. These are the event counts stated in the registry record for that group. The record does not list top serious adverse event terms.
In general, an at-risk count describes the group represented in a safety summary, while an affected count describes how many participants were recorded as having an event in that category. These figures should be read as registry-reported counts, not as proof that no adverse event could occur. Zero recorded events in a study group cannot establish absence of risk, particularly when the record does not provide event narratives, collection procedures, follow-up completeness, or additional safety detail. Such details are not reported in the registry record.
The 171 subjects at risk in the safety entry should not be assumed to equal the number enrolled or the number included in the primary visual-acuity analysis. The registry records 176 enrolled, while the number with primary outcome data is not reported in the registry record. Safety counts and efficacy-analysis populations can differ, and the record does not explain any difference between them.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, open-label, single-group evaluation was conducted and defines binocular logMAR visual acuity at the 2-week follow-up as the primary outcome. It describes the measurement conditions, scale direction, and analysis population. It also records a safety summary for the test group. These details explain what the study intended to measure and how the endpoint is framed.
What the record does not establish is the numerical visual-acuity outcome. The mean, standard deviation, number with outcome data, and confidence interval are not reported in the registry record. Without those results, readers cannot quantify the observed acuity, assess its variability, or judge the precision of the estimate. Nor can they assess numerical results for the listed secondary outcomes, which are not reported in the registry record.
Even if a follow-up mean were available, a single-group study would describe measurements in the participants observed, rather than provide a randomized comparison with another lens or a control condition. The design cannot by itself establish that any observed score was caused by the test lens. Open-label conduct and the absence of a recorded comparator also limit the ability to distinguish intervention-related changes from other influences. The record does not report a baseline-to-follow-up primary contrast.
The safety entry reports no serious adverse events, other adverse events, or deaths among the subjects counted at risk. These counts describe what is recorded, not a guarantee that the intervention has no risks. Further information about safety ascertainment and event details is not reported in the registry record.
Accordingly, the available registry information supports a description of the study design, endpoint definition, enrollment, and listed safety counts. It does not support a quantitative conclusion about visual-acuity performance, statistical significance, precision, or comparative effect. Those conclusions would require outcome estimates and analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of how a clear endpoint definition and a limited design can coexist with incomplete outcome reporting. The registry identifies binocular logMAR visual acuity, the testing conditions, the follow-up timeframe, and the population intended for the primary outcome. Those details help readers understand what an eventual numerical estimate would represent.
The scale's direction is also explicit: scores closer to zero or below zero indicate better visual acuity, and 0.0 corresponds to Snellen 20/20. That information is essential for interpreting the sign and magnitude of any reported score. But without a mean, standard deviation, or interval estimate, the registry record does not show the measured level or its precision. A well-defined endpoint cannot substitute for an estimate.
The single-group, open-label design highlights an important distinction between describing outcomes and estimating comparative effects. Measurements in the test group could describe observed performance, but a concurrent comparator would be needed for a controlled treatment contrast. The record does not include such a group. This means the design's strongest statistical role is descriptive, and causal claims would require evidence beyond the recorded design and endpoint definitions.
The record also lists multiple outcome measures and analyses without reporting a detailed analysis plan. This makes it difficult to assess how different outcomes were prioritized, whether analyses were prespecified, and how multiplicity was considered. Missing information about the number with follow-up data and handling of missing values further limits evaluation of the analysis population.
Finally, the distinction between enrollment, safety counts, and outcome-analysis counts matters. The study enrolled 176 participants, the safety group lists 171 at risk, and the primary analysis population requires 2-week data. These are different recorded concepts, and the number contributing to the primary endpoint is not reported in the registry record. Keeping these distinctions clear prevents enrollment or safety figures from being mistaken for endpoint evidence.
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 direct limitation for interpreting the study is that numerical primary outcome results are not reported in the registry record. The mean logMAR score, standard deviation, confidence interval, and number contributing data are all absent. Numerical results for the listed secondary outcomes are also not reported. Without these estimates, the observed magnitude and precision of the measured outcomes cannot be evaluated.
The design is single-group, open-label, and has no recorded comparator. As a result, it does not support a controlled comparison between the test lens and another intervention. The record does not list randomization or masking. These design features limit the ability to distinguish observations associated with lens use from other possible influences and do not establish a causal effect.
The primary population includes dispensed subjects with 2-week data regardless of protocol deviation, but the number meeting that definition is not reported in the registry record. The amount and pattern of missing outcome data, reasons for missingness, and methods for handling missing values are also not reported. This prevents assessment of follow-up completeness and the possible influence of missing observations.
The registry lists 10 outcome measures and 16 analyses, but does not describe their relationship, prespecification, multiplicity handling, or a detailed statistical analysis plan. Interim analyses are not reported in the registry record. The trial's sample-size justification and rationale for the enrollment target are likewise not reported in the registry record; a planning illustration is not the trial's own design.
Additional details about measurement standardization, assessor procedures, participant characteristics beyond the stated eligibility description, and subgroup results are not reported in the registry record. These limitations concern what can be assessed from the registry information; they do not establish that unreported procedures or analyses were or were not performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses — NCT06377488.
- Registry record last updated 2025-10-28; status last verified 2025-10.
- Results first posted 2025-07-09.
- 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
NCT06377488 is a completed, open-label, single-group device study sponsored by Johnson & Johnson Vision Care, Inc. The registry records 176 enrolled participants, a start date of 2024-04-22, and a primary completion date of 2024-06-24. The study evaluated a daily disposable multifocal toric lens made from Senofilcon A (C3) material with a UV blocker and HEV filter.
The primary outcome is mean binocular logMAR visual acuity under high luminance, high contrast conditions at the 2-week follow-up. The registry defines distance, near, and intermediate assessment conditions and specifies an analysis population of dispensed subjects with follow-up data, regardless of protocol deviation. The numerical primary and secondary outcome results are not reported in the registry record.
The safety entry lists 171 subjects at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. The record lists 10 outcome measures and 16 analyses, but detailed statistical methods, missing-data handling, multiplicity procedures, and the trial's sample-size justification are not reported in the registry record.