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 Dailies Total 1 Sphere Contact Lenses (NCT05239494), a na na study. The primary outcome is Visual Analog Scale (VAS) Contact Lenses Comfort Scores.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05239494 |
| Phase | NA |
| Condition | Dry Eye, Contact Lens Complication |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Alabama at Birmingham |
| Results posted | Yes |
2. Clinical Question
Population
The study focused on past contact lens wearers who had stopped wearing lenses because of dryness or contact lens discomfort. The registry describes adults aged 18 to 40 years, inclusive, and says candidates were recruited through clinic records, email and fliers, then pre-screened by telephone using an Institutional Review Board-approved questionnaire. The full eligibility criteria are not reported in the registry record.
Intervention
All participants were asked to wear Dailies Total1 Sphere contact lenses for the duration of the study. This is a single-group study, so the intervention is the lens-wearing experience being assessed rather than one of multiple randomized treatments.
Comparator
No concurrent comparator group is recorded. The study therefore does not directly compare Dailies Total1 Sphere with another lens, usual care, or no lens wear. Participants’ earlier experiences with other lenses are part of the reason they were recruited, not a randomized control condition.
Primary question
The stated aim was to assess whether past wearers who stopped because of dryness or discomfort could comfortably wear Dailies Total1 Sphere. The primary endpoint is the median comfort score on a visual analog scale at the one-month visit. The registry describes scores greater than 0 as comfortable, but does not report the observed median, its inter-quartile range, or the proportion meeting a defined success criterion. Consequently, the recorded endpoint does not establish a reported frequency of successful refitting.
3. Trial Design
This is a completed, single-group device study listed under the title “Dailies Total 1 Sphere Contact Lenses.” The official title frames the study around how the lens performs among people who previously stopped wearing contact lenses because of comfort or dryness. The registry lists 60 participants as the enrollment. All participants were asked to wear Dailies Total1 for the duration of the study.
The design is not a randomized comparison: allocation is recorded as NA, and there is no like-for-like control arm. Masking is recorded as none. The study is classified as phase NA. These entries describe the registry record and should not be interpreted as evidence about design features beyond those recorded. The protocol’s fuller design details are not reported in the registry record.
The study start date is 2022-05-23, the primary completion date is 2023-08-30, and the overall status is completed. The primary endpoint is a median visual analog scale comfort score at the one-month visit. A Likert questionnaire is listed as a secondary outcome. The registry lists 2 outcome measures and 1 analysis, but does not report enough detail to describe the analysis methods or the findings for those measures.
Because everyone received the same lens intervention, the study can describe outcomes in the treated group if those results are reported. It cannot, by design, isolate a comparative effect against another lens or control condition. Recruitment procedures and a partial population description appear in the record, but the full eligibility criteria and study procedures are not reported in 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.
Overall Study
| Stage | Dailies Total1 |
|---|---|
| STARTED | 60 |
| COMPLETED | 59 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Dailies Total1 |
|---|---|
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: Subjects were recruited via clinic records, email and fliers, and they were pre-screened with an Institutional Review Board (IRB)- approved qualification questionnaire over the telephone. Adult, 18- to 40-year-old (inclusive), past CL wearers who had a Logarithm of the Minimum Angle of Resolution (logMAR) best-corrected visual acuity of 0.00 or better were recruited. Subjects were required to have worn CLs for at least 1year in the past.
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 | Dailies Total1 |
|---|---|---|
| Participants analysed | 60 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 60 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 24 (18 to 40) |
| Sex: Female, Male: Female | Participants | 42 |
| Sex: Female, Male: Male | Participants | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 59 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 6 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 51 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 60 |
6. Primary Endpoint
The registry lists the primary outcome as Visual Analog Scale (VAS) Contact Lenses Comfort Scores, measured over 1 month.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the median score on a visual analog scale (VAS) for contact lens comfort at the one-month visit. The scale runs from -50 to +50, with scores greater than 0 described as comfortable. The median represents the middle of the observed score distribution: it is a measure of the typical participant score that is less affected by unusually high or low observations than the mean can be. The inter-quartile range (IQR), the specified measure of dispersion, describes the middle portion of the score distribution and helps convey how much participants’ scores varied.
Comfort is relevant to the study’s stated question because participants had previously stopped wearing lenses due to dryness or discomfort. A standardized score can characterize their reported comfort after wearing the study lens. However, a median score is not itself a proportion of participants who could wear the lens comfortably. The registry does not report a threshold-based success definition or the primary result, including the median and IQR. It also does not report how participants who did not complete the visit were handled. Thus, the endpoint’s stated scale and timing are clear, but its observed distribution and relationship to a successful-refitting frequency cannot be assessed from the registry record.
In general, self-reported scales measure participants’ experiences rather than an objective physical quantity. Their interpretation depends on the scale definition, the timing of measurement, and the analysis population. Those general considerations do not fill in the missing endpoint results or protocol details.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a single-group study of Dailies Total1 Sphere in people who had previously stopped wearing contact lenses because of dryness or discomfort. The stated primary outcome is a median comfort score at the one-month visit. Yet the registry record does not report the observed score, its inter-quartile range, or another estimate of comfort. No conclusion about the measured comfort level or its variability can therefore be drawn from the posted results.
The record’s stated aim includes determining how often these past wearers could comfortably wear the study lens. That question concerns a frequency or proportion. The specified primary endpoint, however, is a median VAS score. The endpoint description says scores greater than 0 are comfortable, but the registry does not report how many participants had scores above that threshold, nor does it specify a separate success rule. A group median alone would not reveal the number of individuals above a cutoff. The posted results therefore do not establish the frequency of successful refitting.
The single-group design also limits interpretation. Since no concurrent comparator is recorded, the study cannot provide a direct contrast with another lens or a control condition. Any outcomes from the group would describe participants’ experience under the study lens, not the relative effect of the lens compared with an alternative. Previous lens use is not a randomized comparison and cannot be treated as one.
The record lists 60 enrolled participants and reports no serious adverse events, no other adverse events, and no deaths in the Dailies Total1 group. Those safety counts are descriptive. Their interpretation depends on the study’s event definitions, observation period and completeness of reporting, details that are not reported in the registry record. Zero recorded events does not establish that risk is absent.
In general, an estimate is more informative when reported with a measure of uncertainty and clear information about the analyzed population. No primary estimate, confidence interval, or analysis-population details are reported in the registry record. The available record supports describing the design, endpoint specification and adverse-event counts, but not estimating the study’s comfort outcome or the precision of that outcome.
9. Statistical Methods Explained
The registry identifies a single-group study and specifies a median VAS comfort score with an inter-quartile range at the one-month visit. It does not report the numerical endpoint result or enough detail to identify the statistical procedure used for the primary analysis. The methods below explain the general meaning of the recorded measures and design; they are not claims about an unreported analysis plan.
What does a median describe?
In general, the median is the midpoint of an ordered set of observations. It describes the central position without requiring the score distribution to be symmetric. This can be useful for rating scales, where a few unusually high or low responses might pull a mean away from the score reported by many participants. The median does not show the full distribution: different sets of individual scores can have the same median.
The registry specifies the IQR as the measure of dispersion. In general, the IQR describes the spread of the middle half of observations, using the first and third quartiles. Reporting a median together with an IQR can convey both a central score and variation among participants. The numerical median and IQR for this endpoint are not reported in the registry record, so the scale’s actual distribution cannot be assessed.
What does the scale threshold mean?
The VAS is described as running from -50 to +50, with scores greater than 0 considered comfortable. This is a scale interpretation stated in the endpoint description. In general, a cutoff turns a continuous score into a classification, but an individual-level cutoff and a group summary answer different questions. A median score does not reveal the proportion of participants above a cutoff. The registry does not report the number or proportion whose scores were greater than 0, and it does not report another prespecified definition of successful lens wear.
What can a single-group design estimate?
In general, a single-group study can describe outcomes measured among participants who receive the intervention. Without a concurrent comparator, it cannot estimate a direct between-group contrast. Changes from an earlier experience, if assessed, would not automatically provide the same evidence as a concurrent randomized comparison: experiences may differ in timing, measurement, participants, and other circumstances. No comparative estimate is reported for this study.
The record lists allocation as NA and masking as none. It does not describe a masking procedure. Because the primary endpoint is a participant-reported comfort score, expectations and awareness of the lens may be relevant considerations in general, but the record does not quantify any such influence. This is a design consideration, not evidence that responses were biased.
How should precision be considered?
In general, a confidence interval gives a range of values compatible with the data under a specified statistical model, and its width conveys precision. The registry record does not report a confidence interval or other interval estimate for the primary outcome. Without the endpoint estimate and its uncertainty, the magnitude and precision of the observed comfort score cannot be evaluated.
The record also describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect; for time-to-event outcomes the illustration uses total events, while other illustrations use participants per arm. These are hypothetical planning assumptions, not a description of the actual single-group study. The registry record does not report the underlying observed effect or a sample-size justification for the study’s own design. Such planning figures, when present, are not observed power and do not substitute for a result with an uncertainty interval.
Why can over-dispersion matter generally?
For count outcomes, a model may assume a particular relationship between the mean and variability. Over-dispersion means the observed variability is greater than that assumption allows; ignoring it can make uncertainty appear smaller than it is. This is a general statistical issue, not a reported feature of this trial. The primary endpoint is a comfort score, and the registry record does not report a count model, an over-dispersion assessment, or a model-based analysis.
Overall, the registry provides the endpoint definition and broad design, but not the primary results or detailed statistical methods. It is therefore not possible to verify which estimator, model, missing-data procedure, or inferential test was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary VAS comfort endpoint and a secondary Likert questionnaire. It also lists 2 outcome measures and 1 analysis. The record does not describe a multiplicity adjustment, a hierarchy of hypotheses, or how the primary and secondary outcomes were handled together. Multiplicity is a general concern when several outcomes or statistical tests are examined: without a prespecified strategy, the chance of at least one apparently notable result can increase. No claims about such a strategy can be made for this study because it is not reported in the registry record.
Missing-data handling is not reported in the registry record. In general, missing observations can affect both the estimate and its precision, especially when the reasons for missingness are related to participants’ experiences or outcomes. The record does not state how many participants contributed a one-month VAS score, whether all enrolled participants completed the visit, how missing scores were treated, or whether any sensitivity analyses were performed.
The analysis population is also not reported in the registry record. The stated enrollment is 60, but the number enrolled does not by itself identify the number included in the primary analysis. No analysis-set definition, such as inclusion based on lens use or visit completion, is given. The record also does not report whether participants were analyzed according to an intention-to-treat principle or another rule. These omissions prevent assessment of how representative the analyzed observations are of all enrolled participants.
These are reporting gaps, not evidence that particular procedures were absent. The registry record does not give enough detail to assess the potential effects of multiplicity, missing observations, or analysis-population choices on the primary result.
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 |
|---|---|---|---|
| Dailies Total1 | 0 | 60 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dailies Total1 | 0 of 60 |
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 |
|---|---|
| Dailies Total1 | 0 of 60 |
The registry reports 0 participants with serious adverse events among 60 at risk in the Dailies Total1 group. It reports 0 participants with other adverse events among 60 at risk and 0 deaths. No serious adverse-event terms are listed. These are the recorded counts for the group, not estimates of comparative safety, because the study has no concurrent comparator.
In general, an adverse-event count describes what was recorded during the observation and under the definitions used in a study. A zero count means no events were reported in that category in this registry entry; it does not show that an event is impossible or that risk is absent. The registry record does not report the event definitions, surveillance procedures, or the duration over which adverse events were collected. Although the primary comfort endpoint is assessed at the one-month visit, the full safety observation period is not reported in the registry record.
The event figures also do not establish whether all participants had complete safety follow-up. That detail is not reported in the registry record. Because no comparison group is included, these counts cannot show how the reported event experience compares with another lens or with no study lens. They should be read as descriptive registry counts, not as a definitive comparative safety assessment.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed study in which 60 participants were asked to wear Dailies Total1 Sphere, with a primary comfort score specified for the one-month visit. It also reports no serious adverse events, no other adverse events, and no deaths in the study group. These registry entries describe the study’s recorded enrollment, endpoint and adverse-event counts.
The record does not report the median VAS score or its IQR. It therefore does not show the observed level or spread of comfort scores. Nor does it report the count or proportion of participants with scores greater than 0. The stated aim of estimating how often past wearers could comfortably wear the lens cannot be answered from a median endpoint description alone, and the registry’s posted results do not provide the frequency estimate.
The study also does not include a recorded comparator group. Its design cannot establish whether outcomes differ from those with another lens or from a control condition. The single-group results, if fully reported, would characterize the enrolled group’s experience and would not by themselves quantify a comparative treatment effect.
In general, interpretation also depends on the analyzed population, completeness of outcome measurement, and precision of estimates. Those details, along with the primary outcome estimate and an interval describing its uncertainty, are not reported in the registry record. The absence of reported results is not evidence of a particular comfort outcome. Similarly, the zero adverse-event counts are not proof that no risk exists, and the record does not describe the duration or completeness of safety follow-up.
The defensible reading is limited: the registry identifies the question, a single-group lens-wearing study, a comfort scale and timing, and descriptive safety counts. It does not report enough outcome information to establish the primary result or its precision.
13. Why This Trial Matters Statistically
This study addresses a measurement and design question that matters for clinical research: how to characterize comfort among people who have already stopped wearing contact lenses because of dryness or discomfort. The registry defines a participant-reported VAS endpoint and a one-month measurement time. It also states that scores greater than 0 are considered comfortable. These details make the intended construct and scale interpretation visible, even though the outcome values are not reported.
The record also illustrates why the choice of summary measure should match the research question. A median comfort score describes the center of a distribution, whereas a question about how often participants can wear a lens comfortably calls for a frequency or proportion based on a clearly defined criterion. The record does not report such a frequency, so the stated aim and the available endpoint results cannot be reconciled through posted outcome values.
Its single-group design is another important statistical feature. Describing outcomes in a selected group may be informative about that group, but without a concurrent comparator it cannot answer a direct comparative question. Statistical interpretation depends not only on whether a score is collected, but also on the design that makes a comparison credible and on reporting estimates with their uncertainty.
Finally, the registry entry demonstrates the limits of reading an outcome from an endpoint definition alone. A scale, threshold and visit time describe what was intended to be measured; they do not reveal what participants reported. The missing primary estimate, dispersion, analysis population and precision prevent readers from assessing the result, regardless of the study’s stated motivation.
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 principal limitation for interpretation is that the registry record does not report the primary outcome values. The median VAS score and IQR at the one-month visit are not given, and no confidence interval or other uncertainty estimate is reported. As a result, the comfort outcome and its precision cannot be evaluated.
The study has a single-group design, with no concurrent comparator recorded. It therefore does not support a direct comparison with another contact lens or a control condition. The primary endpoint is a median comfort score, while the stated aim concerns the frequency of comfortable wear; no participant count or proportion above the stated threshold is reported, and a separate definition of successful refitting is not reported in the registry record.
The registry describes adults aged 18 to 40 years, inclusive, who were past contact lens wearers, and identifies dryness or discomfort as the reasons for prior discontinuation. However, the full eligibility criteria are not reported in the registry record. The primary population description is incomplete, so additional selection criteria cannot be assessed. Recruitment through clinic records, email and fliers, followed by telephone pre-screening, is recorded, but details of participation and representativeness are not reported.
Missing-data procedures, the analyzed population, and the number contributing primary scores are not reported in the registry record. The statistical analysis methods and any multiplicity plan are also not described. For safety, the record lists zero events but does not report event definitions or the full observation period. These are limits of the available registry information; they do not establish that a particular method or procedure was not used in the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dailies Total 1 Sphere Contact Lenses — NCT05239494.
- Registry record last updated 2024-10-01; status last verified 2024-09.
- Results first posted 2024-09-19.
- 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
The registry record identifies NCT05239494 as a completed, single-group study of Dailies Total1 Sphere contact lenses, sponsored by the University of Alabama at Birmingham. Enrollment is 60. The study started on 2022-05-23, and primary completion is recorded as 2023-08-30. Allocation is listed as NA, masking as none, and phase as NA.
All participants were asked to wear Dailies Total1 for the study duration. The primary outcome is median VAS contact lens comfort at the one-month visit, with an IQR specified and scores greater than 0 described as comfortable. A Likert questionnaire is listed as a secondary outcome. The primary result and its dispersion are not reported in the registry record.
The record reports 0 serious adverse events among 60 at risk, 0 other adverse events among 60 at risk, and 0 deaths. No serious adverse-event terms are listed. The registry does not report a concurrent comparator, detailed analysis methods, missing-data handling, or analysis-population definition.