Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere (NCT06817785), a non-randomized na study. The primary outcome is Lens Comfort.

2. Clinical Question

3. Trial Design

This completed study compared two soft contact lenses in participants with myopia. The registry record lists an enrollment of 45 and identifies the study as nonrandomized, single-masked, and crossover. Its intervention descriptions say that all participants would wear Lens 1 (ocufilcon D) for 15 minutes in Period 1 and Lens 2 (somofilcon A) for 15 minutes in Period 2. Thus, the described design has each participant use both lenses in a stated sequence, rather than assigning different participants to independent lens groups.

The fixed sequence in those descriptions matters for interpretation. A difference between comfort ratings could reflect the lens, but it could also be influenced by the period in which the lens was worn, experience from the first period, or other time-related changes. These are general considerations for crossover studies; the registry record does not report whether the sequence was varied, whether a washout was used, or how period effects were handled in analysis. Because allocation is listed as nonrandomized, the record does not support treating the comparison as a randomized, like-for-like control comparison.

Masking is listed as single, but the identity of the masked party is not reported in the registry record. The record lists the study as completed, with a start date of 2025-01-24 and primary completion date of 2025-02-25. These dates and the completed status describe the study record, but they do not establish how many participants completed both periods or contributed to the primary analysis. The number analyzed is not reported in the registry record.

The primary outcome is lens comfort immediately after lens application. The record lists one outcome measure and no analysis records. It does not report numerical comfort estimates, an estimated contrast between lenses, a confidence interval, or a statistical test for the primary outcome. Therefore, the design and intended measurement can be described, but the comparative result cannot be reconstructed from 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.

Before assignment: Forty Five participants were screened. All the participants who were eligible in the study were included in the analysis. (n=45)

Lens 1 (15 minutes)

Lens 2 (15 minutes)

Analysis population for the primary outcome, as defined in the registry: Overall number of participants analyzed

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 Lens Comfort, measured over Immediately after lens application.

The primary endpoint is lens comfort immediately after lens application. It is measured on a scale from 0 to 100, where 0 means worst and 100 means best. The record specifies a mean as the summary measure and standard deviation as the measure of dispersion. A mean describes the average rating in an analyzed group; a standard deviation describes how spread out individual ratings are around that average.

Comfort is used as a participant-reported experience of wearing the lenses. Measuring it immediately after application focuses the assessment on the early wearing experience, rather than comfort over a longer wearing period. That timing also limits what the endpoint can say: it does not, by itself, describe comfort later in the day or during extended use. The registry record does not report the wording or administration details of the rating question beyond the scale and timing.

For a comparison, the mean comfort rating for each lens and an appropriate contrast would be needed, together with information about uncertainty. None of those numerical primary outcome results is reported in the registry record. The record also does not give the number of participants included in the endpoint analysis. Enrollment alone cannot fill that gap, because the number enrolled need not equal the number analyzed.

As a general statistical point, a mean provides a concise summary but does not show the full distribution of ratings. The spread and shape of the responses can matter, particularly if ratings cluster near an endpoint of the scale or vary substantially among participants. Without outcome summaries or participant-level data, the registry record does not permit assessment of those features.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For a continuous outcome such as a comfort rating, an analysis commonly summarizes observations using a mean and a measure of spread. The registry record specifies the mean and standard deviation. The mean is the arithmetic average of the analyzed ratings; the standard deviation describes their variability around that average. These are general definitions. The record does not include the observed means or standard deviations for either lens, so no outcome estimate can be interpreted from those summary measures in this case.

What does a crossover design change?

In a crossover study, participants receive or use more than one intervention in sequence. A comparison can use the within-participant pairing: each participant's response under one condition is compared with that same participant's response under another. This can reduce the influence of stable participant characteristics that affect ratings, because those characteristics are shared within the pair. That potential benefit depends on appropriate design and analysis. The registry record identifies a crossover model and says all participants wear both lenses, but it does not report the statistical method used for paired observations.

Sequence and period are important in crossover studies. Period refers to the position of an intervention in the sequence. The record assigns Lens 1 to Period 1 and Lens 2 to Period 2 in its descriptions. If all participants follow that same order, a difference between periods can be difficult to distinguish from a difference between lenses. Familiarity with rating comfort, changes in the wearing experience, or a lingering effect from an earlier period are general possibilities that may matter in a sequential comparison. The record does not report a sequence-randomization procedure, a washout interval, or analyses of period or carryover effects. Their absence from the record should not be taken as proof that such procedures were or were not used outside the registry entry.

Why does the allocation designation matter?

Random allocation is a method for assigning interventions by chance. It can help balance measured and unmeasured characteristics between groups on average, although it does not guarantee balance in any particular trial. This study is identified as nonrandomized, and the intervention descriptions indicate that all participants wore both lenses in the same stated sequence. It should therefore not be described as a randomized comparison. For a crossover design, variation in treatment sequence can also help separate treatment effects from period effects. Whether any such variation occurred is not reported in the registry record.

The single-masking label indicates that the record classifies the study as masked, but does not identify who was masked. That detail matters because expectations can influence subjective ratings, and the possibility of such influence depends in part on who knew which lens was being worn. No further masking procedure is reported. It would be inappropriate to infer that participants, assessors, or analysts were specifically masked based only on the single-masking label.

How should uncertainty be understood?

A confidence interval is a statistical summary of uncertainty around an estimate. In general, it shows a range of values that are compatible with the observed data and the chosen method, under that method's assumptions. It is useful to consider both the estimated difference and its interval: a point estimate alone does not convey precision. The registry record reports no comfort estimate or confidence interval, so neither the magnitude nor precision of a lens contrast can be assessed. A p-value, if reported, would address compatibility with a specified null model; it would not by itself convey the size or practical importance of a difference. No primary-outcome p-value is reported.

Standard deviation and confidence interval answer different questions. Standard deviation describes variation among individual observations, while a confidence interval describes uncertainty in an estimated quantity. Neither is reported numerically for the primary outcome. The endpoint description specifies standard deviation as the dispersion measure, but that specification is not an observed result.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such calculations are planning tools: they ask how many participants per arm would be needed under chosen assumptions to detect a target effect with a chosen power. They are not observed outcomes, and they are not the same as an estimate of power after the study has finished.

Those assumptions cannot be used to infer a numerical sample-size result without the observed effect and the corresponding calculated outputs. The record does not report the observed comfort effect or analysis results. The planning assumptions are also not evidence that these were the study's original design assumptions; the record characterizes them as an illustration rather than the trial's own design. No sample-size justification or power calculation for the trial's design is reported in the registry record.

More generally, a calculation based on an observed effect can be sensitive to how that effect was estimated. If the initial estimate is uncertain, planning around it may not represent a stable target. A fraction of an effect is an assumption about the size worth detecting, not an outcome finding. These points describe general statistical interpretation and do not establish that a particular calculation was performed or that a particular sample size was appropriate for this study.

Finally, the registry record lists no analysis records. Without a reported analysis method, outcome estimate, or uncertainty measure, the statistical procedure and its assumptions cannot be evaluated. The design labels and endpoint definitions help explain what the study set out to measure; they do not substitute for a reported analysis.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Lens 1 (Ocufilcon D)", "Lens 2 (Somofilcon A)")
n   <- c(45, 45)
m   <- c(88, 93)
sp  <- c(14, 8)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Lens 1 (Ocufilcon D)  45  88.000  14.000  83.794  92.206
CARM  Lens 2 (Somofilcon A)  45  93.000  8.000  90.597  95.403

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure, identified as lens comfort, and lists no analysis records. It does not report a multiplicity plan or explain whether any additional outcomes or statistical comparisons were considered outside the listed measure. Multiplicity refers generally to the increased chance of a false-positive finding when several hypotheses are tested. Whether and how that issue was handled is not reported in the registry record. With no primary-outcome test result reported, there is no inferential result for which an adjustment can be evaluated.

Information about missing outcome data is also not reported in the registry record. The endpoint population is described as the overall number of participants analyzed, but the number analyzed is not stated. The record does not report how many participants posted a comfort rating for each lens, whether any ratings were missing, why any data might be missing, or how missing observations were handled. Those details matter because an analysis based only on available ratings can be affected if the absence of a rating is related to the participant's experience or other factors.

The enrollment of 45 should not be read as the number analyzed. Enrollment describes the study record's enrollment figure; it does not establish completion of both lens periods or availability of endpoint measurements. The record does not describe an analysis population beyond its general wording for the primary outcome, nor does it state whether the analysis used all available observations, complete pairs, or another approach.

These reporting gaps prevent assessment of the analysis population, missing-data assumptions, and multiplicity handling. They do not establish that data were missing or that multiplicity adjustments were required; they mean those matters are not reported in the registry record.

12. 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 registry record reports safety counts separately for Lens 1 (ocufilcon D) and Lens 2 (somofilcon A). For each lens, 45 participants are listed at risk for serious adverse events and 0 are listed as affected. For each lens, 45 are also listed at risk for other adverse events and 0 are listed as affected. Deaths are listed as 0 for each lens.

These figures describe the reported counts in the registry record. They do not establish that no adverse events occurred outside the recorded categories or reporting period, and they do not demonstrate that the lenses have identical safety profiles. The record does not provide event-level descriptions, follow-up details, or additional information about how adverse events were collected and attributed. It also does not report the number analyzed for the comfort endpoint, which should not be inferred from the safety denominators.

Zero reported affected participants is a count, not proof of zero risk. Safety interpretation depends on the observation period, completeness of reporting, event definitions, and the amount of information available. Those details are not reported in the registry record. The counts should therefore be read as the adverse-event figures recorded for each lens, rather than as a comprehensive estimate of risk.

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

The registry record establishes that a completed, nonrandomized crossover study was intended to compare two soft contact lenses on immediate comfort ratings. It specifies a comfort scale from 0 to 100, the timing of measurement, and the planned summary as a mean with standard deviation. It also reports safety counts for each lens. These details help define the question and the kind of evidence the study was intended to produce.

The record does not report numerical comfort results. It therefore cannot show whether average ratings differed, which lens received higher ratings, how large any difference was, or how precise an estimate might be. The absence of a reported result is not evidence that the lenses performed the same, nor is it evidence that one performed better. No conclusion about a comfort difference can be drawn from the design description alone.

Even with numerical results, the design would shape interpretation. The study is labeled nonrandomized, and its descriptions put Lens 1 in Period 1 and Lens 2 in Period 2 for all participants. Period and sequence effects would therefore be relevant considerations. The record does not describe how those issues were addressed, identify the masked party, or report the statistical analysis. Those limitations would need to be considered alongside any reported estimate.

The safety figures are similarly bounded. They record zero affected participants for the serious and other adverse-event categories and zero deaths for each lens, among the participants listed at risk. Those counts do not prove absence of risk or establish comparative safety, particularly without further event and follow-up details.

The most defensible reading is that the registry record documents the study's intended comparison and selected safety counts, but does not supply the outcome analysis needed to answer the primary comfort question. The record supports neither a claim of benefit nor a claim of no difference.

14. Why This Trial Matters Statistically

This study illustrates why design labels and outcome results need to be read together. A crossover design can make within-participant comparisons possible, which may account for stable differences in how participants use a rating scale. But a crossover comparison also depends on how treatment order and period are handled. Here, the registry descriptions assign Lens 1 to Period 1 and Lens 2 to Period 2 for all participants, while allocation is labeled nonrandomized. That makes period and sequence important considerations when assessing any eventual contrast.

The endpoint is subjective comfort measured immediately after application. A clearly defined scale and assessment time help specify what is being measured, but they do not show the observed responses. For a useful statistical interpretation, readers need estimates, dispersion, and uncertainty, along with the analyzed population and the method used to account for the paired design. Those results and methods are not reported in the registry record.

The record also demonstrates the distinction between enrollment and analysis. An enrollment figure does not establish how many participants contributed complete ratings for both periods. Without the analysis population and missing-data information, readers cannot judge the completeness of the endpoint data or the basis of the comparison.

Finally, planning illustrations based on an observed effect are conceptually different from trial outcomes and from the trial's original design justification. Their assumptions do not supply missing results or establish achieved power. In this record, the distinction is especially important because no observed comfort effect or analysis is reported.

Statistically, the study's question is understandable, but the registry record alone does not provide enough information to estimate or evaluate the comparative comfort result. This is a useful reminder that a defined endpoint and completed status are not substitutes for a reported analysis.

15. 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.

Several limitations specific to this study affect what can be learned from the registry record. First, numerical results for the primary comfort endpoint are not reported. Without means, standard deviations, a lens contrast, or an uncertainty interval, neither the direction nor precision of the comparison can be evaluated. The registry record lists no analysis records.

Second, the study is described as nonrandomized and crossover, with all participants assigned to wear Lens 1 in Period 1 and Lens 2 in Period 2. This stated order makes a lens comparison potentially entangled with period effects. The registry record does not report whether sequence variation, a washout period, or statistical adjustment for period or carryover was used. These omissions limit assessment of the comparison; they do not establish what procedures may have occurred outside the registry entry.

Third, the masking description is incomplete for interpretation. The record labels the study single-masked but does not identify who was masked or describe the masking procedure. Because comfort is a subjective rating, the information about masking would help readers assess possible influences on reporting.

Fourth, the number analyzed for comfort and the handling of missing ratings are not reported. Enrollment is stated as 45, but the record does not say how many participants contributed ratings for both lenses or whether observations were excluded. This prevents assessment of completeness and of the analysis population.

Finally, the registry record does not report a statistical analysis plan, an approach to multiplicity, or a trial-specific sample-size justification. The planning assumptions described for an illustration are not a substitute for those details. The primary endpoint is measured immediately after application, so it also does not characterize comfort over longer wear. Together, these limitations restrict interpretation to the study's stated question and design rather than a conclusion about comparative performance.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere — NCT06817785.
• Registry record last updated 2026-08-31; status last verified 2026-04.
• Results first posted 2026-08-31.
• 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.

19. Record Summary

The completed study, NCT06817785, is titled Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere. It concerns myopia and lists an enrollment of 45. The record identifies the design as nonrandomized, single-masked, and crossover. All participants were described as wearing Lens 1 (ocufilcon D) for 15 minutes in Period 1 and Lens 2 (somofilcon A) for 15 minutes in Period 2.

The primary outcome is mean lens comfort immediately after application, measured on a scale from 0 to 100, with standard deviation specified as the dispersion measure. Numerical outcome results and the number analyzed are not reported in the registry record. No analysis records are listed. Safety counts report zero affected participants for serious and other adverse events, and zero deaths, for each lens group.

The registry record lists a start date of 2025-01-24, a primary completion date of 2025-02-25, and a completed status. The stated design and endpoint define the intended comparison, but the record does not report the analysis needed to determine the comparative comfort result.