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 Investigation of Wearing Compliance of Spectacles for Myopia Control (NCT06590441), a registered phase not stated study. The primary outcome is Effect of Sex on Overall Wearing Pattern.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06590441 |
| Phase | Phase not stated |
| Condition | Myopia |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | CooperVision, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Juvenile myopia control spectacle wearers who had established use of the spectacles for at least 3 months. The study enrolled 53 participants; further demographic details are not reported in the registry record.
Intervention
Use of myopia control spectacles, with wearing and removal periods assessed using temperature sensors fitted to the spectacle frames. This is an observational study, so the spectacles are the device under observation rather than a randomized treatment assignment.
Comparator
The primary question concerns sex-related differences in wearing pattern. Sex-specific group counts and any other comparison group are not reported in the registry record. The record does not describe a randomized control group.
Primary question
Does overall daily spectacle-wearing time differ by sex among established juvenile wearers? The endpoint is described using least-squares means and 95% confidence intervals for two summaries of wearing time: a 24-hour period and a waking-day period.
The study’s stated aim was to compare wearing patterns of spectacles prescribed for myopia control in juvenile wearers. The registry identifies sex as the primary comparison of interest, rather than a comparison of spectacle use with no spectacle use or with another device. It therefore addresses how long participants wore their spectacles, and whether the measured pattern varied by sex, within the enrolled group.
The registry describes a multisite observational investigation and lists 53 enrolled participants. It does not report the number of participants in each sex group, the participants’ ages, or other characteristics that would help describe who contributed to the comparison. Nor does it report numerical estimates of wearing time or the sex contrast. The question is specified, but the posted record does not provide the outcome results needed to judge the size or precision of any difference.
3. Trial Design
This was a completed observational study of myopia control spectacle use. The registry lists the study as multisite, with enrollment of 53, and describes the participants as established juvenile myopia control spectacle wearers, defined in the arm description as having used the spectacles for at least 3 months. The listed intervention is a device: myopia control spectacles. The registry record does not describe a randomized assignment or a like-for-like control arm; allocation is not stated.
The wearing pattern was assessed with temperature sensors fitted to spectacle frames. According to the primary outcome description, readings from the final week of the one-month study were used to determine when spectacles were worn or removed. The timeframe is also described as continuous measurement over 1 week of wear. No further sensor-processing or quality-control details are reported in the registry record.
The primary outcome is titled Effect of Sex on Overall Wearing Pattern. Wearing time was summarized over a 24-hour period, W24, and over a waking-day period from 07:00 to 21:00, W14. The registry says the outcome parameter was a least-squares mean and that dispersion was to be expressed with a 95% confidence interval. It does not identify the statistical model, covariates, or test used to estimate the sex comparison.
The registry gives a start date of 2024-09-30, a primary completion date of 2025-01-18, and a completed status. It lists two outcome measures and zero analyses. The result values, the number analyzed for each outcome, and participant flow after enrollment are not reported in the registry record. Completion status alone does not establish that results were posted or that every enrolled participant contributed usable sensor data.
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 | Myopia Control Spectacles |
|---|---|
| STARTED | 53 |
| COMPLETED | 53 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Data for one participant was not available due to a failure of the sensors
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 | Myopia Control Spectacles |
|---|---|---|
| Participants analysed | 53 | |
| Age, Continuous | years | 11.2 (SD 2.0) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 24 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Effect of Sex on Overall Wearing Pattern, measured over Measured continuously over 1 week of wear.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Hours in a day |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns overall spectacle-wearing time, assessed using temperature sensors fitted to the spectacle frames. The registry states that temperature readings from the final week of the one-month study were used to determine when spectacles were worn or removed. The timeframe is described as continuous measurement over 1 week of wear.
Wearing time was summarized in two ways. W24 represents the average over a 24-hour period. W14 represents the average over the defined waking-day period, 07:00 to 21:00. The registry states that a higher score indicates spectacles were worn for a longer period per day. Reporting both summaries distinguishes total daily wear from wear during the specified waking hours; they are related measures, but their time windows differ.
The primary outcome focuses on the effect of sex on these wearing patterns. The specified summary is a least-squares mean, accompanied by a 95% confidence interval. In general, a confidence interval conveys uncertainty around an estimated quantity; without the actual estimates and interval limits, the amount of uncertainty cannot be assessed. The registry record does not report numerical W24 or W14 values, sex-specific estimates, a contrast between groups, or confidence-interval limits. Consequently, the endpoint and its measurement approach are described, but the observed wearing pattern and the precision of the sex comparison cannot be read from the registry results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a clear measurement question: among established juvenile spectacle wearers, assess whether overall wearing patterns differ by sex. It specifies that wearing was inferred from temperature readings at the spectacle frames and summarized over both a full 24-hour period and a waking-day window. These details define what the primary endpoint was intended to represent.
However, the record does not report the numerical primary outcome results. It gives no W24 or W14 least-squares means, no sex-specific estimates, no estimated difference between sexes, and no confidence-interval limits. It also gives no test statistic or p-value. Without these results, it is not possible to describe the direction, magnitude, or precision of a sex-related difference from the registry record. The endpoint title should not be read as evidence that a difference was found.
Least-squares means are the stated outcome parameter, but the registry does not name the model or explain what, if anything, was adjusted for. In general, a least-squares mean is an estimate derived from a statistical model and may reflect adjustment for variables included in that model. Without the model specification, readers cannot determine the basis of the estimates, whether adjustment was used, or how that approach relates to the observed data.
The study is observational. The registry does not state allocation to groups and does not describe a randomized comparison. The primary comparison is by sex within a group of spectacle wearers, not a randomized contrast of spectacle use against an alternative. Any difference in wearing time between sex groups, if one were reported, would be an association in this study population. It would not by itself establish that sex caused a difference in wearing behavior, nor would it establish an effect of the spectacles compared with another strategy.
The record lists enrollment of 53, but does not report sex-group sizes or the number contributing data to either endpoint. The total enrollment therefore does not establish the precision of the comparison. Precision depends on the data contributing to the estimates and on their variability, neither of which is given. Although the planned reporting format includes 95% confidence intervals, their omission means the uncertainty around any sex comparison cannot be evaluated.
The posted record lists two outcome measures and zero analyses, while providing no numerical results for the primary endpoint. The stated completion status and dates do not fill this results gap. They describe the administrative status and timing recorded for the study, not the observed outcome values. The appropriate reading is therefore limited: the registry describes how wearing time was measured and what comparison was intended, but does not provide enough outcome information to characterize what the data showed.
9. Statistical Methods Explained
What does the primary endpoint summarize?
The outcome is a continuous measure of spectacle-wearing time, expressed in hours in a day. The registry defines two time windows: W24, an average over a 24-hour period, and W14, an average over the waking-day period from 07:00 to 21:00. A higher score is described as indicating longer daily wear. The measurements came from temperature sensors attached to spectacle frames, with readings from the final week of the one-month study used to infer when spectacles were worn or removed.
In general, continuous outcomes preserve information about the amount of a measured quantity rather than reducing it to categories such as wore or did not wear. Here, the endpoint is intended to represent duration of wear. The registry does not explain sensor thresholds, how ambiguous temperature readings were handled, or how missing intervals were treated. Those details matter because they determine how raw sensor readings become daily wearing-time summaries.
What does a least-squares mean mean?
The registry identifies the primary outcome parameter as a least-squares mean. In general, this is a mean estimated from a statistical model, rather than necessarily being the simple arithmetic average of the observed values. Depending on the model, such estimates can account for specified factors or provide estimates at a defined set of covariate values. The registry record does not name the model, identify covariates, or say whether estimates were adjusted. It is therefore not possible to determine which model-based interpretation applies to this analysis.
The outcome description also specifies a 95% confidence interval. In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the method used to calculate it. A narrower interval indicates greater precision than a wider interval, while an interval that includes a particular comparison value may be compatible with a range of possible effects. These interpretations require the estimate and interval limits. The registry record does not report either, so the precision of the primary estimates cannot be assessed.
What would an over-dispersed outcome mean in general?
Over-dispersion is a general issue in statistical modeling when the variability in observed data is greater than the model’s assumptions allow. If that extra variability is not accounted for, standard errors and confidence intervals can be too small, making results appear more precise than they are. This concept is relevant to some outcome types and models, but the registry describes a continuous wearing-time endpoint and does not identify the model or report a dispersion assessment. There is no basis in the record to say that over-dispersion was present or that any particular correction was used.
What can be inferred from the comparison?
The primary comparison is the effect of sex on overall wearing pattern. In general, an observational comparison describes differences between groups as measured; it does not ensure that the groups are otherwise comparable. The registry does not report sex-group counts, group characteristics, adjustment variables, or the method used for the comparison. It also does not describe a randomized allocation. Any causal interpretation would therefore require information and assumptions that are not reported in the registry record.
The record says the parameter is a least-squares mean, but it does not state whether the main result was a difference between means, a test of an overall sex effect, or another contrast. It does not report a p-value or other test result. There is thus no basis for identifying a particular hypothesis test or deciding whether the analysis used a one- or two-sided test. Such details should not be inferred from the endpoint title or from the use of a confidence interval.
How should the planning calculations be understood?
Sample-size illustrations are planning calculations, not observed outcomes. The stated assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set to a stated fraction of the observed effect. In general, such calculations show how a hypothetical future design might be sized under chosen assumptions; they do not reveal how many participants were needed for this observational study, and they are not observed power.
The planning assumptions do not establish that the actual study used equal allocation, a normal approximation, or the stated significance level. The registry does not report a sample-size justification for the study’s design. The numeric planning results and the observed effect magnitude are not reported in the registry record, so no specific planning estimate can be interpreted from these details alone. Any planning illustration should be read as conditional on its assumptions, not as a description of the trial’s actual allocation or analysis.
In general, power is a design property calculated for a specified effect size, variability, analysis, and sample size. It is not a measure of whether an observed result is true, nor does a non-significant result demonstrate absence of an effect. Because the registry record does not report the primary outcome estimates or the analysis details, neither the precision of the observed comparison nor the study’s ability to detect a particular effect can be assessed from the posted results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and identifies the effect of sex on overall wearing pattern as the primary outcome. That primary outcome includes W24 and W14 summaries, based on different time windows. The record does not explain whether these were treated as separate primary tests, how they were related in the analysis, or whether any multiplicity adjustment was planned. A prespecified strategy for handling multiple outcomes or comparisons is not reported in the registry record.
Multiplicity is a general concern when several hypotheses are tested: considering more tests can increase the chance of at least one apparently notable result by chance. Possible approaches include identifying one primary comparison, adjusting inference, or clearly labeling other analyses as exploratory. The registry does not provide enough information to determine which approach, if any, was used. It also lists zero analyses and does not report test results, so the effect of any multiplicity strategy cannot be evaluated.
Missing-data handling is also not described. The record does not report how many participants had usable sensor data, how incomplete periods were treated, whether participants with partial measurements were included, or whether any imputation was used. These details are important for sensor-based outcomes because gaps in measurement could affect estimates of daily wear. The number enrolled is not necessarily the number analyzed for either outcome.
The analysis populations are not reported in the registry record. There is no description of inclusion criteria for the analytic dataset, exclusions after enrollment, or a participant flow accounting. The record does not state whether the primary outcome analysis included every enrolled participant or a subset with complete measurements. Without these details, readers cannot assess whether missing data or exclusions could have influenced the estimated wearing patterns.
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 |
|---|---|---|---|
| Myopia Control Spectacles | 0 | 53 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Myopia Control Spectacles | 0 of 53 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Myopia Control Spectacles | 0 of 53 |
The registry reports serious adverse event counts for the Myopia Control Spectacles group. It lists 53 participants at risk and 0 affected by serious adverse events. For other adverse events, it also lists 53 at risk and 0 affected. The number of deaths is recorded as 0. No serious adverse event terms are listed.
These counts describe what was entered in the registry for the specified group. They do not provide event narratives, severity details beyond the serious-event classification, or a breakdown by event type. The record also does not describe how adverse events were collected, the monitoring period used for the safety summary, or how complete ascertainment was assessed. Those details are not reported in the registry record.
Zero events recorded is not the same as proof that no event could occur, and these counts should not be interpreted as a comparison of safety between groups. The registry does not describe a separate comparator group for this safety summary. The counts are descriptive of the reported study group and do not establish relative safety or risk outside the participants and observation captured by the record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed multisite observational study enrolled 53 established juvenile myopia control spectacle wearers and set out to assess wearing patterns by sex. Its measurement approach used temperature sensors fitted to spectacle frames, with wearing time summarized over both a full 24-hour window and a defined waking-day window. This provides a description of the intended endpoint and the means of measurement.
What the record does not establish is the observed wearing time or whether the sex comparison showed a difference. No numerical least-squares means, group estimates, comparison estimate, confidence-interval limits, or p-values are reported. As a result, the direction and size of any difference, and the precision with which it was estimated, cannot be determined from the registry results. The primary outcome title is not itself a result.
Even if numerical differences were available, the observational design would shape their interpretation. A measured association between sex and wearing pattern would not, on its own, show that sex caused the difference. The registry does not report group characteristics or the analysis model, and it does not describe random assignment. It also does not provide a comparison of myopia control spectacles against another device or against no spectacle use.
The outcome is about duration of wear, not a clinical measure of myopia progression or another health outcome. The registry’s stated question concerns wearing compliance and does not report a clinical outcome comparison. Therefore, the record cannot establish what wearing patterns imply for clinical outcomes. The measurement period and participant group also limit interpretation: the endpoint is based on the specified sensor-reading period among established juvenile wearers, not a description of all potential users or all periods of use.
The adverse-event summary records no serious adverse events, other adverse events, or deaths in the listed group, but it does not provide details of ascertainment or a comparative safety analysis. Taken together, the posted record describes the study’s purpose, population, measurement, and reported event counts, while leaving the primary efficacy-style comparison without numerical outcome results. Conclusions about the size, certainty, or clinical significance of a sex-related wearing-pattern difference are not supported by the information reported.
13. Why This Trial Matters Statistically
This study is statistically notable because its central outcome is measured continuously from wearable sensor data rather than reported as a simple participant-level category. The endpoint aims to capture duration of spectacle use, with separate summaries for a full 24-hour period and a defined waking-day period. Those summaries make the time window part of the estimand: the question about total daily wear is not identical to the question about wear within waking hours.
The registry also makes clear that the comparison is observational and organized around sex. That distinction matters when interpreting estimates. A group contrast can describe measured patterns, but a causal explanation requires more than a difference in group means. Information about group composition, confounding control, and the fitted model is absent from the record, so the analytic basis for any adjusted comparison cannot be examined.
Precision is central to interpreting continuous outcomes. Reporting least-squares means with 95% confidence intervals would ordinarily allow readers to consider both the estimated wearing pattern and its uncertainty. In this registry record, however, the numerical estimates and interval limits are not reported. The planned form of reporting therefore cannot substitute for the results themselves.
There is also a practical measurement issue: sensor readings must be converted into intervals classified as wear or removal and then into daily summaries. The registry describes the sensor placement and general purpose but does not report the specific processing rules, handling of gaps, or data completeness. Such details are relevant to reproducibility and to understanding whether the derived measure reflects everyday wear consistently.
Finally, the record illustrates why study status and enrollment should be separated from outcome reporting. The study is marked completed and lists 53 enrolled participants, but those details do not show the primary estimates, the number analyzed, or the uncertainty of the comparison. The statistical value of the registry entry is therefore in clarifying the target question and measurement framework, while also exposing how much interpretation depends on complete results and analysis details.
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.
A central limitation for interpretation is that the registry record does not report numerical results for the primary endpoint. The specified least-squares means and 95% confidence intervals are not accompanied by estimates or interval limits, and no sex-comparison result or p-value is given. Consequently, the size, direction, and precision of the primary comparison cannot be assessed.
The study is described as observational, and allocation is not stated. The registry does not describe a randomized comparison or a like-for-like control group. It also does not report sex-specific participant counts, demographic characteristics, or other factors that might differ between groups. These omissions prevent assessment of group comparability and of the role of potential confounding in the sex comparison.
Details of the statistical analysis are limited. The registry names least-squares means but does not identify the model, covariates, handling of repeated measurements, or inferential test. The analysis populations and number of participants contributing data are not reported. Nor are sensor-data completeness, exclusions, missing-data methods, or the treatment of partial measurement periods described.
The measurement approach is specified at a high level, but the registry does not explain how temperature readings were classified as wear or removal, how daily summaries were calculated from incomplete readings, or how measurement quality was checked. Such implementation details would help readers assess reproducibility and potential measurement error.
The registry lists two outcome measures but does not report a multiplicity strategy. It also provides no sample-size justification for the actual study design. The planning assumptions described for illustrations do not establish the study’s design assumptions or analysis plan. Finally, the stated outcome is wearing duration; the record does not report a clinical outcome tied to myopia progression. These limitations restrict conclusions to the study’s stated measurement objective and the information recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Investigation of Wearing Compliance of Spectacles for Myopia Control — NCT06590441.
- Registry record last updated 2025-11-25; status last verified 2025-10.
- Results first posted 2025-11-25.
- 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
NCT06590441, Investigation of Wearing Compliance of Spectacles for Myopia Control, is listed as a completed multisite observational study sponsored by CooperVision, Inc. The registry records a start date of 2024-09-30, primary completion on 2025-01-18, and enrollment of 53.
The participants are described as established juvenile myopia control spectacle wearers, with established use defined as at least 3 months. Temperature sensors fitted to spectacle frames were used to assess wearing and removal. The primary question concerns the effect of sex on overall wearing pattern, summarized as W24 and W14 wearing time and specified as least-squares means with 95% confidence intervals.
The registry lists two outcome measures and zero analyses. Numerical primary outcome results, sex-group counts, analysis details, and missing-data methods are not reported in the registry record. The adverse-event summary lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 53 participants at risk.