Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers (NCT05938010), a registered phase not stated study. The primary outcome is Satisfaction With Comfort of T30fA Lens.

2. Clinical Question

In practical terms, the question is how participants described comfort with the study lens after the specified wearing period. This is a subjective outcome: it captures participants’ own ratings rather than an objective measurement of lens performance. Such ratings can be relevant to a study of wearing experience, but their interpretation depends on how the question was administered, who provided ratings, and how the responses were handled. Those details are not reported in the registry record.

The study title and description situate the question among people who were already satisfied with their Biofinity Toric lenses. That context matters when considering whom the findings could describe. It does not, by itself, establish that the study compared the lenses under randomized or otherwise equivalent conditions. The registry record explicitly does not characterize this as a randomized comparison and states that the arms are not a like-for-like control comparison. Most importantly, the primary comfort outcome is specified, but its observed result is not reported in the registry record. The question can therefore be described, but the posted record does not answer it numerically.

3. Trial Design

The registry record identifies a completed study titled “Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers.” Its brief description says the aim was to subjectively evaluate wearing experience in the T30fA lens among subjects already satisfied with Biofinity Toric lenses. Astigmatism is the listed condition, and enrollment is recorded as 42. The study sponsor is Scripps Poway Eyecare and Optometry.

The recorded study start date is 2023-07-25, and the primary completion date is 2023-09-26. The status is COMPLETED. The intervention is recorded as a device: Dailies Total1® contact lenses for astigmatism (T30fA). The primary outcome is satisfaction with comfort after 1 month of wear, expressed as a median and inter-quartile range. The registry record describes a rating scale from 0 to 10, with the ends labeled not satisfactory at all and extremely satisfactory.

The record does not establish a randomized comparison: allocation is not stated, and the registry description warns that the arms are not a like-for-like control comparison. The description of participants as satisfied Biofinity Toric wearers provides context about their prior experience, but it does not show that prior-lens ratings were collected as a concurrent comparator. The listed intervention and outcome information should therefore be read as a description of the planned assessment, not evidence of a controlled treatment contrast.

Five outcome measures are listed, while no analyses are listed. The record does not report the number of participants contributing data to the primary outcome, the analysis population, whether follow-up was complete, or the statistical procedures used for the outcome. Nor does it report the primary outcome values. These omissions limit what can be inferred from the completed status and enrollment figure: completion describes the registry status, but does not establish that every enrolled participant contributed an outcome or that the primary result is available.

The registry record does not report a protocol rationale for the design, a sample-size justification, interim analyses, or a detailed statistical analysis plan. Those details cannot be inferred from the study title, enrollment, or completion status.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Satisfaction With Comfort of T30fA Lens, measured over After 1 month of wear.

The primary endpoint is satisfaction with comfort of the T30fA lens after 1 month of wear. Participants were to rate comfort on a scale from 0 to 10, where 0 means not satisfactory at all and 10 means extremely satisfactory. The endpoint is summarized as a median and inter-quartile range. The median describes the midpoint of the ordered ratings, while the inter-quartile range describes the spread of the middle portion of those ratings. These summaries can be useful when responses are ordinal or do not follow a symmetric distribution, because they do not require describing the outcome with a mean and standard deviation.

As a general statistical point, a comfort rating captures a participant’s own assessment. It addresses perceived experience, rather than a directly measured physical property of a lens. A rating scale can make responses easier to summarize, but interpretation depends on the wording, administration, and completeness of the ratings. The registry record gives the scale anchors and assessment timing, but does not report details such as the exact question administration, how incomplete responses were handled, or whether participants rated more than one lens using the same procedure.

The endpoint is relevant to the study’s stated focus on subjective wearing experience. Its summary would describe the ratings recorded in the analyzed participants; without a suitable comparison, it would not by itself estimate a causal difference between lenses. In this case, the planned summary statistic is stated, but the observed median and inter-quartile range are not reported in the registry record. The endpoint’s definition is therefore available, while its numerical result and precision are not.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record specifies a median and inter-quartile range for the primary comfort outcome. These are descriptive summaries rather than, by themselves, tests of a hypothesis. The median represents the central position of ordered ratings. The inter-quartile range describes the span from the lower to the upper quartile and conveys how dispersed the middle half of the observations is. In general, these summaries can be appropriate for bounded rating scales, especially when the distribution is skewed or when equal spacing between adjacent response values is not assumed. The registry record does not provide the observed summaries, so none can be interpreted for this study.

What would the median and inter-quartile range tell a reader?

In general, the median offers a compact description of the center of responses, but it does not say whether most participants gave similar ratings or whether the responses were divided into different patterns. The inter-quartile range adds information about spread, but it does not describe the tails or identify individual responses. A full distribution can sometimes add useful context to these summaries. The registry record does not report a distribution of the comfort ratings, participant-level values, or a plot of those values.

The scale runs from 0 to 10 and includes verbal descriptions of its endpoints. Because it is bounded, a rating cannot extend beyond those stated limits. General statistical interpretation should account for that boundary: the scale’s limits may constrain the possible values and may affect how a distribution looks. The rating is also subjective, so the meaning of a particular response depends on the question and circumstances of assessment. The registry record does not report evidence about the scale’s measurement properties or a threshold for interpreting a rating as meaningfully different.

What does a comparison require?

As a general principle, a comparative effect requires a clearly defined contrast between groups or conditions and a method for estimating that contrast. Random allocation can help make comparison groups similar on average, but the registry record does not state that allocation was randomized. It explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. The record describes participants who were already satisfied with Biofinity Toric lenses, but does not establish that those prior experiences constitute a concurrent control condition. A contrast between prior experience and a later rating, if one were made, would need to account for the way the two experiences were measured and for the order in which they occurred; those details are not reported in the registry record.

Uncertainty is often expressed with a confidence interval. In general, such an interval represents a range of estimates compatible with the data and the assumptions of the analysis; it is not a guarantee that the true value lies within the particular interval. Its width depends on factors such as the amount of information and variability. No confidence interval or other inferential estimate for the primary endpoint is reported in the registry record. Therefore, there is no study-specific interval width or uncertainty estimate to interpret.

What do the analysis listings establish?

The registry record lists five outcome measures and no analyses. The outcome-measure count indicates that outcomes are listed, but it does not establish that their results were posted. The absence of listed analyses means that the record does not identify a statistical test, model, adjustment strategy, or inferential contrast for those outcomes. It would be inappropriate to infer the choice of method from the median-and-inter-quartile-range endpoint description alone. A descriptive summary and a statistical test answer different questions, and the planned descriptive summary does not reveal whether any formal comparison was intended.

In general, analysis decisions can include how to handle repeated measurements, how to address missing ratings, and whether to adjust for other variables. None of those procedures is reported in the registry record. There is also no reported protocol rationale, sample-size justification, or interim-analysis plan. These should remain unknown rather than being reconstructed from the enrollment figure or completion status.

How should planning calculations be read?

General sample-size illustrations are planning tools: they describe how many participants per arm might be needed under stated assumptions to detect a specified effect with a chosen power. They are not a measure of the probability that the completed study found an effect, and they must not be described as observed power. The planning assumptions associated with this record specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event illustrations, the stated quantity is the total number of events using the Schoenfeld approach; other illustrations use participants per arm.

Those assumptions describe a planning framework, not the trial’s documented design or a reported analysis. The record does not report a sample-size justification for the trial itself. Moreover, the registry record does not report the primary endpoint estimate or its analysis, and does not establish a like-for-like two-arm comparison. Any planning illustration should therefore be kept separate from the observed study findings and from a claim about the trial’s actual power. The registry record does not provide a study-specific primary outcome result from which precision or statistical significance can be assessed.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures and no analyses. It does not report a multiplicity strategy, such as identifying a hierarchy of outcomes or adjusting inference across multiple tests. Without reported analyses, it is not possible to determine whether multiple statistical comparisons were conducted or how their interpretation was handled. General statistical context is that testing several outcomes can increase the chance of a false-positive finding when each is treated as a separate opportunity for evidence. Whether that issue arose in this study cannot be established from the registry record.

The primary outcome is clearly identified as satisfaction with comfort after 1 month of wear, with a planned median and inter-quartile range. However, its observed values are not reported. The record also does not report outcome-specific analysis populations, the number of participants contributing to each measure, or whether any outcomes were changed or omitted. No such decisions should be inferred from the number of registered measures alone.

Missing-data procedures are not reported in the registry record. There is no description of how absent ratings were handled, whether any imputation was used, or whether analyses were restricted to participants with available responses. The enrollment figure of 42 is not a substitute for the number analyzed for a particular endpoint. The registry record also does not report an analysis population definition or participant flow that would allow those quantities to be reconciled.

As a general matter, missing outcome data can affect both the representativeness of a summary and the uncertainty around it. The direction and size of any effect depend on why data are missing and on the assumptions used to address them. Because the record does not describe missingness or its handling, those assumptions and their consequences cannot be evaluated. The statistical analysis plan, multiplicity approach, and missing-data strategy are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The safety record lists 0 serious adverse events among 40 at risk for Dailies Total1® contact lenses for astigmatism (T30fA), and 0 deaths. It also lists 0 other adverse events among 40 at risk. These are counts as recorded in the registry, not estimates of a comparative safety effect. The enrollment figure is 42, while the safety entry gives 40 at risk; the registry record does not explain the difference, so the figures should not be reconciled by assumption.

A count of zero means that no events in the relevant category are recorded for the stated group in the posted safety data. It does not, by itself, show that the risk is absent, nor does it establish how safety compares with another lens. Interpretation depends on the event definitions, observation period, ascertainment, and completeness of reporting. Details about those matters are not reported in the registry record. The zero counts also do not answer the primary comfort-satisfaction question, which is a separate outcome and has no posted result.

General statistical context is that sparse or zero event counts can leave considerable uncertainty about the underlying event rate, particularly when the number at risk and observation period are limited. No rate, confidence interval, or comparative safety analysis is reported in the registry record. These entries should therefore be read narrowly as the posted counts, rather than as proof that no safety events could occur.

12. What the Result Does, and Does Not, Mean

The registry record establishes the topic and structure of the planned assessment: subjective comfort satisfaction with T30fA after 1 month of wear among people described as already satisfied with Biofinity Toric lenses. It specifies a 0-to-10 rating scale, a median and inter-quartile range as the primary outcome summary, enrollment of 42, and a COMPLETED status. Those details explain what the study set out to assess and how the primary outcome was defined.

They do not establish what participants rated. The registry record does not report the primary median, inter-quartile range, or an analysis of the primary outcome. No result can therefore be characterized as high, low, consistent, variable, statistically significant, or precise on the basis of this record. The fact that the study is marked completed does not supply the missing results.

The record also does not establish that T30fA was compared with Biofinity Toric under equivalent conditions. It states that allocation is not reported and that the arms are not a like-for-like control comparison. The participants’ prior satisfaction with Biofinity Toric is background to the study question, not proof of a controlled comparison. Accordingly, the posted information does not support attributing any difference in experience to a lens, and it does not provide a comparative effect estimate.

More generally, a subjective rating is evidence about the responses collected from the participants assessed. It is not automatically a measure of every aspect of lens performance or of experience in people outside the study population. The registry record does not report participant characteristics or the number contributing to the primary endpoint, which further limits assessment of who the results might describe even if outcome values were available.

The safety entries record 0 serious adverse events and 0 deaths among 40 at risk, but these counts do not replace the missing comfort outcome or establish comparative safety. The appropriate conclusion is limited: the registry record describes a completed study and a defined subjective endpoint, but it does not report the numerical primary result or analyses needed to judge the observed experience or its uncertainty.

13. Why This Trial Matters Statistically

This trial matters statistically because its central question concerns a patient-reported, bounded rating rather than an objective measurement. The registry record’s choice of a median and inter-quartile range highlights that the outcome is intended to be summarized through the center and spread of participants’ ratings. Those summaries can communicate the pattern of a rating scale without assuming that its values behave like a continuous measurement with symmetric variation. But a suitable summary cannot substitute for the actual observed data, which are not reported in the registry record.

The record also illustrates the importance of separating a study question from a comparative claim. The study focuses on T30fA experience among people already satisfied with Biofinity Toric lenses, yet the registry information does not establish randomized allocation or a like-for-like control comparison. In general, design determines which contrasts can be interpreted and how confidently differences can be attributed to an intervention. A prior lens experience may provide context, but it should not be treated as a concurrent control without evidence that the design and measurement support that interpretation.

Enrollment, completion status, and outcome reporting answer different questions. Enrollment records the planned or registered study size; completion indicates the registry status; outcome results show what was observed. Here, enrollment is listed as 42 and status is COMPLETED, but the primary outcome values and analyses are not reported. This makes clear why study status alone cannot be used as evidence about the magnitude, direction, or precision of a result.

Finally, the presence of several outcome measures makes transparency about analysis choices important. The record lists five measures but no analyses, and does not report multiplicity handling, missing-data methods, or analysis populations. These gaps do not prove that an analysis was inappropriate; they mean the posted record does not let readers evaluate those choices. The statistical value of the record is therefore chiefly in its description of the question, endpoint, timing, and design limitations, rather than in evidence about an observed treatment effect.

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 primary limitation for interpreting this study is that the registry record does not report the primary comfort outcome values. The endpoint is described in detail, including its scale and assessment timing, but no median or inter-quartile range is posted. The record also lists no analyses. This prevents assessment of the observed response distribution, uncertainty, or any statistical comparison.

The design information does not support a straightforward comparison between T30fA and Biofinity Toric. The registry record says allocation is not stated and that the arms are not a like-for-like control comparison. Although participants are described as satisfied with Biofinity Toric lenses, the record does not establish whether prior and study-lens experiences were measured concurrently or under comparable conditions. A causal contrast should not be inferred.

Enrollment is recorded as 42, but the number included in the primary endpoint analysis is not reported. The safety group lists 40 at risk, and the registry record does not explain the relationship between that count and enrollment. Participant characteristics, endpoint completion, and analysis-population definitions are also not reported. Consequently, the representativeness of any outcome summary cannot be assessed from the record.

The record does not report how missing ratings were handled, whether any statistical tests or adjustments were used, or how the five listed outcomes were considered together. It also does not report the trial’s sample-size justification, interim analyses, or detailed statistical analysis plan. These omissions leave important aspects of precision and analysis conduct unclear.

Finally, the safety entries are limited to posted counts: 0 serious adverse events and 0 deaths among 40 at risk. Event definitions, ascertainment details, and the safety observation period are not reported in the registry record. These limitations do not establish that the study had problems; they define what can and cannot be evaluated from the posted information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Subjective Wearing Experience of the Total30 for Astigmatism Lens Among Satisfied Biofinity Toric Lens Wearers — NCT05938010.
• Registry record last updated 2024-11-14; status last verified 2024-08.
• Results first posted 2024-11-14.
• 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.

18. Record Summary

The registry record is for NCT05938010, a COMPLETED study sponsored by Scripps Poway Eyecare and Optometry. It lists astigmatism as the condition, enrollment of 42, a start date of 2023-07-25, and a primary completion date of 2023-09-26. The study concerns subjective wearing experience with Dailies Total1® contact lenses for astigmatism (T30fA) among people already satisfied with Biofinity Toric lenses.

The primary outcome is satisfaction with comfort after 1 month of wear, rated from 0 to 10 and specified for summary by the median and inter-quartile range. Five outcome measures are listed, but no analyses are listed. The primary outcome values and statistical analysis are not reported in the registry record. Allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison.

The safety entry reports 0 serious adverse events among 40 at risk and 0 deaths. Missing-data methods, analysis populations, multiplicity handling, and a detailed statistical plan are not reported in the registry record. The posted information describes the study question and outcome definition but does not provide the primary numerical result needed to assess the observed comfort ratings.