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 Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses (NCT05805085), a non-randomized na study. The primary outcome is Subjective Handling at Insertion, Dispensing Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05805085 |
| Phase | NA |
| Condition | Astigmatism |
| Allocation | Non-Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | CooperVision, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with astigmatism were enrolled. The registry record lists an enrollment of 40. It does not report further eligibility details or a description of the population’s characteristics.
Intervention
Lens A, identified in the official title as Biomedics 1 Day Toric, was worn for 15 minutes during Period 1. The study evaluated participants’ subjective experiences with daily disposable toric contact lenses.
Comparator
Lens B, identified in the official title as MyDay Toric, was worn for 15 minutes during Period 2. The registry lists the study as non-randomized, so the lens periods should not be treated as a randomized, like-for-like control comparison.
Primary question
The primary endpoint was subjective handling at insertion at the dispensing visit, assessed on a 0-100 scale after 15 minutes of wear. The registry record does not report the observed score for either lens, an estimated difference, or an inferential test. It therefore identifies the question the study set out to assess, but does not establish how participants rated either lens or how the ratings compared.
3. Trial Design
The registry record describes a completed device study of Biomedics 1 Day Toric and MyDay Toric, listed in the study details as Lens A and Lens B. It records 40 participants enrolled and astigmatism as the condition. The study began on 2023-01-10, reached primary completion on 2023-11-16, and has a completed status.
The design is listed as crossover, with non-randomized allocation and single masking. Participants wore Lens A for 15 minutes in Period 1 and Lens B for 15 minutes in Period 2. The record does not describe how participants were assigned to a sequence, who was masked, or whether a washout period was used. Those details are not reported in the registry record and should not be inferred from the design labels.
In general, a crossover design evaluates more than one intervention within participants, so comparisons may use within-participant information. Such a design also requires attention to period effects, sequence, and possible carryover. The record does not report how those issues were handled or whether the statistical analysis accounted for them. Because allocation is explicitly non-randomized, the listed lens periods do not constitute a randomized comparison. The record does not provide a protocol-level explanation of allocation or a sample-size justification.
The study lists two outcome measures and zero analyses. The primary outcome is described, but the other outcome and the results for either outcome are not reported in the registry record. No statistical analysis results are posted.
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.
Period 1: Lens A, 15 Minutes
| Stage | Lens A | Lens B |
|---|---|---|
| STARTED | 40 | 0 |
| COMPLETED | 40 | 0 |
| NOT COMPLETED | 0 | 0 |
Period 2: Lens B, 15 Minutes
| Stage | Lens A | Lens B |
|---|---|---|
| STARTED | 0 | 40 |
| COMPLETED | 0 | 40 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | All Study Participants |
|---|---|---|
| Participants analysed | 40 | |
| Age, Continuous: Male | years | 27.10 (SD 6.04) |
| Age, Continuous: Female | years | 27.08 (SD 6.17) |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 13 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Subjective Handling at Insertion, Dispensing Visit, measured over 15 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled Subjective Handling at Insertion, Dispensing Visit. It measures a participant’s subjective assessment of handling and lens insertion on a scale from 0 to 100, with 100 meaning Excellent, very easy and 0 meaning Very difficult to manage. The score was collected once at the end of 15 minutes of wear. The record describes the measure as a mean with standard deviation as its dispersion.
General: A patient-reported handling score can capture ease or difficulty as experienced by the person using a device. A continuous scale preserves degrees of response rather than reducing experience to a simple yes-or-no category. A mean describes the central score across observations, while a standard deviation describes how spread out those scores are. Neither statistic is reported for this endpoint in the registry record, so its observed level and variability cannot be characterized.
The endpoint is relevant to the study’s stated focus on subjective experiences of daily disposable toric lenses. However, the registry record does not report how the scale was developed or validated, or whether participants received instructions beyond the scale anchors. It also does not report the primary endpoint results for either lens or a comparison between them.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record provides the study design and endpoint definition, but not the numerical primary outcome results. It does not report a mean handling score, standard deviation, confidence interval, estimated contrast between lenses, or p-value. Consequently, the record cannot show the direction, size, or precision of any observed difference in subjective handling. The absence of these results is not evidence that the scores were alike or that there was no difference.
The design description says participants wore Lens A in Period 1 and Lens B in Period 2, each for 15 minutes. It also identifies allocation as non-randomized. The listed periods therefore cannot be interpreted as randomized treatment assignments, and any comparison would need to be understood in light of the allocation and period structure. The registry record does not report the analysis method or whether a within-participant comparison was made.
General: An estimate describes the observed contrast, while a confidence interval expresses uncertainty around that estimate under the method used to calculate it. A narrow interval generally indicates greater precision than a wide interval, but interpretation also depends on the measure and study design. Here, no estimate or interval is reported, so precision cannot be assessed. A p-value, even if available, would not by itself describe the size or practical importance of a difference.
The registry lists 40 participants enrolled and records 40 at risk for each lens in the adverse-event information. Those figures do not supply outcome results or establish how many participants contributed primary endpoint data. The analysis population and missing-data handling are not reported in the registry record.
The record states that the study is completed, but completion status is not a substitute for posted outcome data. It does not report whether analyses were conducted outside the registry, nor does it give a reason for the absence of posted analyses. Conclusions about subjective handling must therefore remain limited to the endpoint definition and study procedures described in the record.
9. Statistical Methods Explained
What does the endpoint summary describe?
The primary endpoint is a continuous score on a 0-100 scale. The registry specifies the mean as the summary measure and standard deviation as the dispersion measure. General: A mean is calculated by combining measured scores into a central summary. A standard deviation describes how much individual scores vary around that mean. Together they can communicate both the average rating and the degree of variation, but they do not reveal the full distribution of responses. The record does not report either statistic for this endpoint.
What does a comparison need to establish?
General: A comparison of two continuous outcomes can be expressed as a contrast between groups or conditions. The estimate conveys the direction and size of the observed contrast, and an uncertainty interval conveys its precision. The choice of method should reflect how observations were collected and the study design. This is especially important in a crossover study, where measurements from the same participant may be related and where period or sequence can matter. The registry record does not report an endpoint contrast, an uncertainty interval, or the method used to analyze the crossover data.
What does non-randomized allocation imply?
The registry explicitly labels allocation as non-randomized. General: Random allocation is one way to reduce systematic differences between treatment groups; without it, observed differences may reflect assignment processes as well as the treatments being compared. In a crossover design, the periods and sequence also matter. The record lists Lens A in Period 1 and Lens B in Period 2, but does not describe assignment procedures or how period effects were addressed. No causal interpretation should be inferred from the design label alone.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe a planning illustration based on an observed effect. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. The record does not provide calculated planning sample sizes or the fractions used. These assumptions are not evidence that the trial was designed using those calculations, and planning illustrations are not observed power.
General: A sample-size calculation asks what amount of data might be needed to detect a defined effect under stated assumptions. Its result depends on the target effect, variability, allocation, significance level, and analysis method. A calculation based on an observed effect is a planning illustration, not a direct measure of how informative a completed study was. Precision in the actual study is better assessed from the observed estimate and its uncertainty interval; neither is reported.
What can be concluded from the posted analysis information?
The registry lists zero analyses. It therefore contains no posted inferential analysis of the primary endpoint. No testing method, model, adjustment, confidence interval, or p-value is reported in the registry record. General: A statistical method should be judged in relation to the outcome type and design, not selected solely from a label such as continuous or crossover. Since the analysis is absent, it is not possible to assess whether the method accounted for paired measurements, period structure, or other relevant features.
The endpoint is recorded once at the end of each 15-minute wear period according to the description. The record does not explain how data from the two periods were combined or contrasted. It also does not report the standard deviation or any other basis for evaluating score variability. As a result, statistical precision, the role of participant-level pairing, and the robustness of any comparison cannot be evaluated from the registry record.
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.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Lens A | 40 | 87.130 | 13.680 | 82.755 to 91.505 |
| Lens B | 40 | 88.500 | 10.140 | 85.257 to 91.743 |
R code and output
arm <- c("Lens A", "Lens B")
n <- c(40, 40)
m <- c(87.13, 88.5)
sp <- c(13.68, 10.14)
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 A 40 87.130 13.680 82.755 91.505
CARM Lens B 40 88.500 10.140 85.257 91.74311. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures but describes only the primary endpoint in the record used for this analysis. The other outcome’s definition and results are not reported in the registry record. It lists zero analyses, so there is no posted set of tests from which to assess how multiple outcomes or comparisons were handled.
General: Multiplicity arises when several outcomes, time points, or statistical comparisons are examined. Conducting many tests can increase the chance that at least one result appears notable by chance. A statistical plan may define a primary outcome, identify secondary outcomes, and specify whether adjustments or a testing hierarchy will be used. The registry record does not report a multiplicity strategy, so it is not possible to determine whether any adjustment was planned or applied.
The record does not report missing primary endpoint observations, the number of participants analyzed, or the analysis population. It also does not describe imputation, exclusion rules, or sensitivity analyses. These omissions matter because the handling of unavailable scores can affect both the estimate and its uncertainty. The enrollment and adverse-event risk figures do not establish how many participants posted endpoint data.
General: An analysis population defines which participants’ data contribute to a particular analysis. In crossover studies, it can also matter whether a participant completed both periods or contributed data from only one. The registry record does not state how such cases were handled. With no posted endpoint analysis, neither the completeness of the data nor the impact of missingness can be assessed.
12. 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 |
|---|---|---|---|
| Lens A | 0 | 40 | 0.0% |
| Lens B | 0 | 40 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Lens A | 0 of 40 |
| Lens B | 0 of 40 |
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 |
|---|---|
| Lens A | 0 of 40 |
| Lens B | 0 of 40 |
The adverse-event record lists 40 participants at risk for Lens A and 40 at risk for Lens B. It reports zero serious adverse events and zero other adverse events for each lens, and zero deaths for each. No serious adverse-event terms are listed. These are the figures recorded in the registry; they are not a substitute for a detailed safety analysis.
General: An at-risk count identifies the denominator associated with an adverse-event entry. Event counts should be interpreted alongside those denominators, the period of observation, event definitions, and completeness of reporting. The registry describes 15 minutes of wear for each lens, but it does not provide additional detail on safety surveillance or the rules for attributing events to a lens.
The record’s zero counts mean that no events are recorded in these categories for the listed groups. They do not establish that an event was impossible, nor do they provide a precise estimate of event frequency beyond the recorded observation. The record does not report whether participants contributed to both lens entries in the adverse-event listing or how the crossover structure was reflected in safety monitoring. No further inference about safety should be drawn from these counts alone.
13. What the Result Does, and Does Not, Mean
The record identifies a study of subjective handling for two daily disposable toric contact lenses, with a 0-100 score assessed after 15 minutes of wear. It describes a completed, non-randomized crossover design and reports an enrollment of 40. These details establish the study question and some features of how the lenses were evaluated.
They do not show what participants’ handling scores were. The registry record does not report means, standard deviations, a comparison estimate, confidence intervals, p-values, or analyses. Therefore, the direction and size of a difference, if any, and the precision of such a difference cannot be determined from the record. Missing results should not be read as evidence of equal outcomes or as evidence of a particular outcome.
General: Statistical evidence is strongest when the estimate, uncertainty, analysis method, and design limitations can be considered together. A numerical result alone does not establish that an observed difference is important, and a non-significant test would not demonstrate equivalence. In this case, no such test or estimate is posted, and the registry does not describe an equivalence or non-inferiority question.
The non-randomized allocation is relevant to interpretation. The record does not explain the assignment process or report how the period structure was incorporated into analysis. It also does not describe missing endpoint data or analysis populations. These gaps prevent an assessment of potential bias, precision, or robustness. The results available in the registry support a description of the design and endpoint, not a comparative conclusion about the lenses.
14. Why This Trial Matters Statistically
This record illustrates an important distinction between a registered research question and posted evidence addressing that question. The study identifies a patient-subjective handling endpoint, its scale anchors, and the assessment timing. However, the primary outcome values and analyses are not reported in the registry record. Without those results, readers cannot evaluate the observed score, variation, comparative estimate, or uncertainty.
The design also makes clear why statistical interpretation requires more than knowing that two conditions were evaluated. The study is labeled as crossover, but allocation is non-randomized, and the lens periods are specified. General: Crossover data can contain paired information, while period, sequence, and carryover may also affect comparisons. Understanding the analysis requires knowing how these features were handled. That information is not reported in the registry record.
The record also lists planning assumptions, but no calculated sample-size values. Such assumptions are not actual outcome evidence and do not show how precise a completed study’s estimate is. This distinction matters because planning calculations and observed analysis answer different questions.
For biostatisticians and clinical researchers, the record is a concise example of the limits of drawing conclusions from registration details alone. The endpoint definition and study structure are informative, while the absent results and methods leave the central comparison unresolved in the registry. Transparent reporting of estimates, uncertainty, analysis populations, and design-specific methods is necessary for a statistical reading of the study’s findings.
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 study-specific details needed to interpret the primary endpoint are not reported in the registry record. It does not provide the endpoint scores or dispersion, a between-lens estimate, an uncertainty interval, or a p-value. It lists zero analyses, leaving the method of analysis unavailable. The second listed outcome measure is not described.
The design is labeled both crossover and non-randomized. Lens A is assigned to Period 1 and Lens B to Period 2 in the arm descriptions, but the record does not explain the allocation process, whether participants followed a single sequence, or how order was determined. It does not report a washout period or discuss potential period or carryover effects. These details should not be assumed.
The record does not report characteristics of the enrolled participants beyond the condition, nor does it provide eligibility criteria or demographic information. It does not report the analysis population, endpoint completeness, missing-data methods, or sensitivity analyses. It also does not provide a sample-size justification or calculated planning values.
For safety, the registry lists zero serious and other adverse events and zero deaths for each lens group, but does not detail surveillance procedures or how the crossover design was reflected in attribution. These reporting limits constrain interpretation; they do not establish that unreported methods or events did or did not occur outside the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses — NCT05805085.
- Registry record last updated 2024-12-12; status last verified 2023-03.
- Results first posted 2024-12-12.
- 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.
19. Record Summary
NCT05805085 is a completed, non-randomized crossover device study sponsored by CooperVision, Inc. It enrolled 40 participants with astigmatism and evaluated Biomedics 1 Day Toric and MyDay Toric, listed as Lens A and Lens B. The registry records 15 minutes of wear for each lens in Period 1 and Period 2.
The primary endpoint was subjective handling at insertion, assessed once after 15 minutes on a 0-100 scale, with higher scores anchored to easier handling. The registry lists two outcome measures and zero analyses, but does not report the primary endpoint results or describe the other outcome. It records zero serious adverse events, zero other adverse events, and zero deaths for each lens group, with 40 at risk in each. Statistical methods for the outcome comparison, analysis populations, and missing-data handling are not reported in the registry record.