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 Evaluation of Wear Experience With a Daily Disposable Contact Lens (NCT04296877), a na na study. The primary outcome is Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04296877 |
| Phase | NA |
| Condition | Contact Lens |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ohio State University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned current two-week contact lens wearers who were fit into daily disposable lenses. The registry lists enrollment of 30 and describes all participants as being in the same arm. The official title identifies the participants as previous Acuvue Oasys lens wearers; the brief description characterizes them as current two-week lens wearers.
Intervention
Participants were fit into daily disposable contact lenses after wearing their optimized habitual lenses for approximately 1 week. They were requested to wear the daily disposable lenses for two weeks, for at least 6 hours per day on 10 days. The registry identifies the intervention as a device.
Comparator
This was a single-arm, non-comparative study, not a randomized comparison. Participants wore both types of lenses, but the record does not identify a formal comparison group or report a comparative analysis. Their habitual lenses provide context for the study sequence, not a like-for-like control group in the posted results.
Primary question
The study asked about participants’ lens-wearing experience as assessed by the Contact Lens Dry Eye Questionnaire (CLDEQ-8) at 2 weeks. The questionnaire measures symptoms while wearing contact lenses, with higher scores indicating worse dry-eye symptoms. The registry record does not report the observed score or an analysis comparing lens types.
3. Trial Design
The registry describes a completed, single-group study of daily disposable contact lens wear experience. Enrollment is listed as 30. The study began on 2020-03-10, had a primary completion date of 2020-12-01, and is marked completed. The sponsor is Ohio State University. The record lists the phase as NA, allocation as NA, and masking as none.
Participants were current two-week contact lens wearers who were fit into daily disposable lenses after wearing optimized habitual lenses for approximately 1 week. They were requested to wear the daily disposable lenses for two weeks, with use for at least 6 hours per day on 10 days. The stated aim was to evaluate wear experience after fitting into a daily disposable lens.
The registry explicitly describes the study as single-arm and non-comparative. Although participants wore both types of lenses, this does not make the study a randomized or controlled comparison. The posted record does not provide a comparison of outcomes between the habitual and daily disposable lenses.
The primary outcome measure is the CLDEQ-8 survey at 2 weeks. The registry lists one outcome measure and no analyses. It does not report a protocol-level statistical plan, a sample-size justification, or details of how adherence to the requested wearing schedule was handled. Those aspects should not be inferred from the study description.
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 | Single Arm Study |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All subjects were in the same arm, and wore both types of lenses. This was not a comparative study.
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.
Population: Participants
| Characteristic | Unit | All Participants Wear Study Daily Disposable Contact Lenses |
|---|---|---|
| Participants analysed | 30 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 30 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 29.1 (SD 7.8) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 11 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 25 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Contact Lens Dry Eye Questionnaire (CLDEQ-8) Survey, measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the Contact Lens Dry Eye Questionnaire (CLDEQ-8) survey, assessed at 2 weeks. The record describes it as an 8 question survey of symptoms while wearing contact lenses. Its possible scores range from 0, indicating no symptoms, to 37, indicating maximum symptoms. Higher scores indicate worsening dry-eye symptoms while wearing lenses.
A symptom questionnaire can give a structured measure of participants’ reported experience rather than relying only on an unstructured description. A consistent scale also makes it possible to summarize responses across participants. The registry specifies the median as the summary measure and the inter-quartile range as the measure of spread. In general, a median describes the central position of observations, while the inter-quartile range describes the spread of the middle half of the observations.
The registry record does not report the median or inter-quartile range, nor does it provide individual scores. Therefore, the direction or size of participants’ reported symptoms cannot be described from the posted results. The endpoint description explains what the questionnaire measures, but it is not itself evidence of an observed outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study is designed to describe wear experience after participants who had been wearing two-week lenses were fit into daily disposable lenses. The primary measure is the CLDEQ-8 survey at 2 weeks. Its scale runs from 0 to 37, with higher scores representing worse dry-eye symptoms while wearing lenses. These details define how a score would be interpreted, but the registry record does not report a score, a median, or an inter-quartile range.
Consequently, the posted record does not establish the level of symptoms reported by participants or the variability in their responses. It also does not report a statistical test, confidence interval, or estimate of change. There is no registry analysis comparing the daily disposable lenses with participants’ habitual lenses. No treatment effect or difference between lens types can be derived from the description of the study sequence alone.
The single-group design is important to interpretation. All participants were in the same arm, and the record states that they wore both types of lenses. However, the study is described as non-comparative, and no like-for-like control comparison is reported. General statistical principle: when a study does not include a formal comparison group and analysis, observed experience cannot be separated from other influences through a between-group estimate. The record does not report whether any within-person comparison was planned or conducted.
The registry lists 30 participants at risk in the safety record and reports zero serious adverse events, zero other adverse events, and zero deaths. These are the recorded safety counts. They do not supply the missing primary symptom result, and they should not be read as a measure of questionnaire responses. The record does not describe the safety reporting period or give additional event details.
Overall, the information supports a description of the study question, its single-group design, the requested lens-wearing schedule, and the questionnaire’s scoring. It does not support a numerical conclusion about symptom experience, a comparison with habitual lenses, or an estimate of precision for the primary outcome. Those outcome findings are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies the primary summary as a median with an inter-quartile range. These statistics are suited to describing the center and spread of observed scores without requiring the mean and standard deviation. General statistical explanation: the median is the middle value when observations are ordered. The inter-quartile range describes the span from the lower quarter of observations to the upper quarter, thereby conveying the spread of the central portion of a distribution. Neither statistic is reported for the CLDEQ-8 outcome in the registry record.
What does the endpoint scale tell the reader?
The CLDEQ-8 assesses symptoms while wearing contact lenses. Its score can range from 0, described as no symptoms, to 37, described as maximum symptoms, and higher values mean worse dry-eye symptoms. That direction is essential for interpretation: a higher score represents greater symptom burden on this measure, not a more favorable experience. The registry record does not give an observed score, so no direction or degree of symptom burden can be attributed to study participants from the posted results.
Why would a confidence interval matter?
General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity, such as a mean, median, or difference. A narrower interval indicates greater precision under the method used; a wider interval indicates greater uncertainty. An interval is not the range containing every individual participant’s score, nor does it by itself show whether a difference is important. No confidence interval for the primary endpoint is reported in the registry record. There is therefore no interval estimate to interpret for this study.
What does the design allow?
The record calls this a single-arm, non-comparative study. Participants were fit into daily disposable lenses after wearing optimized habitual lenses for approximately 1 week, then were asked to wear the daily disposable lenses for two weeks. The record also says participants wore both types of lenses. General statistical explanation: observing people at more than one stage does not, by itself, establish that an analysis compared those stages or controlled for changes over time. The registry record does not report such an analysis. It lists no analyses, so no test statistic, p-value, or comparative estimate is available.
The allocation field is marked NA and masking is listed as none. The study is not described as a randomized comparison. It would therefore be inappropriate to treat one group as a randomized control for another or to infer a causal contrast between the lens types from this record.
How should the planning illustration be read?
The registry 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. The effect to detect is described as a stated fraction of the observed effect. Such an illustration is a planning exercise, not a report of the study’s design or a measure of the study’s achieved power. It is not observed power. The registry record does not report the trial’s own sample-size justification, and no observed primary endpoint value or analysis is reported to interpret as the basis for a clinical conclusion.
General statistical explanation: sample-size planning depends on an assumed effect, variability, significance level, allocation, and analysis method. Changing assumptions can change the resulting planning estimate. A planning estimate does not show what effect was observed, and it cannot substitute for an outcome estimate with an uncertainty interval. The planning description in the registry should therefore be kept separate from the study’s reported results.
What can be inferred from the analysis record?
The registry lists one outcome measure and zero analyses. This indicates that the posted record does not contain an analysis result for the primary endpoint. It does not establish whether analyses were performed outside the registry record, or what choices were made in any unreported analysis. Details of the statistical model, handling of repeated observations, missing responses, and analysis population are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, the CLDEQ-8 survey, as the primary endpoint. It does not report a multiplicity procedure or explain how multiple hypotheses or outcomes, if any, were handled. With no analyses listed, the posted record gives no basis for assessing whether any adjustment for multiple testing was used. General statistical explanation: when several statistical tests are conducted, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for multiplicity. That principle does not establish that multiple tests were performed in this study.
Missing-data methods and the amount of missing endpoint data are not reported in the registry record. The record does not state how incomplete questionnaires, missed visits, or deviations from the requested wearing schedule were handled. It would not be appropriate to assume that all participants posted complete endpoint data or that any particular imputation method was used.
The analysis population is not reported in the registry record. The record identifies all study participants as being in the same arm, but it does not say whether the primary analysis included all enrolled participants, only those completing the requested lens-wearing schedule, or another defined group. The requested wearing schedule is not, by itself, a definition of the analysis population.
These reporting gaps limit evaluation of how the primary endpoint was analyzed and how robust any result would be to missing data or alternative analysis choices. Since the registry record does not report an endpoint result or analysis, the potential influence of these choices cannot be assessed from the posted information.
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 |
|---|---|---|---|
| All Study Participants | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Study Participants | 0 of 30 |
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 |
|---|---|
| All Study Participants | 0 of 30 |
The registry safety record lists 30 participants at risk. It records zero serious adverse events, zero other adverse events, and zero deaths. No serious adverse event terms are listed. These figures describe the counts recorded in the registry; they are not a comparison with another group.
The record does not specify the safety reporting period, provide event descriptions, or state additional details about how events were collected or classified. The zero counts should therefore be read narrowly as the recorded figures, not as proof that no events occurred outside the record or that risks are absent. The safety counts also do not provide information about the CLDEQ-8 symptom scores, which are reported as a separate primary outcome. No safety conclusion beyond the recorded counts can be drawn from the information in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group study evaluated wear experience after current two-week lens wearers were fit into daily disposable contact lenses. Participants were asked to wear those lenses for two weeks, with a minimum of at least 6 hours per day on 10 days. The primary measure was the CLDEQ-8 survey at 2 weeks, a symptom scale on which higher scores indicate worse dry-eye symptoms while wearing lenses.
The record does not report the observed CLDEQ-8 score, its median, its inter-quartile range, or any analysis result. It therefore does not show the level or spread of reported symptoms. Nor does it give a statistical estimate of change or a formal comparison between the daily disposable lenses and the habitual lenses.
This absence of a posted outcome should not be interpreted as a score of zero, as no change, or as evidence that symptoms were better or worse. It means that the primary numerical result is not reported in the registry record. The record’s non-comparative design also means that the study description alone cannot support a causal comparison between lens types.
The safety record reports zero serious adverse events, zero other adverse events, and zero deaths among 30 participants at risk. Those recorded counts are relevant to the safety information available, but they do not fill the gap in the primary symptom outcome. Overall, the registry supports understanding what was studied and how the endpoint was defined, but it does not provide the outcome data needed to characterize participants’ reported wear experience.
13. Why This Trial Matters Statistically
This study is a useful example of why design and results need to be read together. Its stated purpose was to evaluate wear experience after fitting current two-week lens wearers into a daily disposable contact lens. The registry identifies a patient-reported symptom measure, a defined scoring direction, and a 2-week assessment timeframe. Those details clarify the question being asked and the kind of outcome intended to address it.
At the same time, the study is explicitly non-comparative and single-group. Participants wore both types of lenses, but that sequence does not establish that a formal comparison was conducted. A description of the design should not be mistaken for an estimate of the difference between lens types. The distinction is important in clinical research: a study can be informative about its measurement and setting while still not answering a comparative question.
The record also illustrates the role of transparent results reporting. Without the primary outcome value, its spread, or an analysis, readers cannot assess the observed symptom experience or its precision. Knowing that the CLDEQ-8 ranges from 0 to 37 and that higher scores are worse explains how results would be interpreted, but it cannot replace the results themselves.
For biostatisticians and clinical researchers, the key lesson is to separate the stated aim, study procedures, endpoint definition, and posted findings. The registry supplies detail on the first three, while the primary numerical findings and analyses are not reported. That distinction prevents study design information from being overread as evidence about an outcome.
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 main limitation for interpretation is that the registry record does not report the primary CLDEQ-8 result or an analysis. No median, inter-quartile range, confidence interval, or test result is available for the stated 2-week assessment. As a result, the primary symptom outcome cannot be characterized numerically from the posted record.
The study is described as single-group and non-comparative. Although participants wore both habitual and daily disposable lenses, the record does not report a formal comparative analysis. The sequence of lens use cannot be treated as a randomized control comparison based on the registry description alone.
The registry lists enrollment of 30, but it does not report the number contributing primary endpoint data or define an analysis population. It also does not report missing-data methods, adherence results, or how departures from the requested wear schedule were handled. These omissions make it impossible to assess whether the primary endpoint summary, if available elsewhere, would represent all enrolled participants or a subset.
Other details relevant to evaluating statistical credibility are not reported in the registry record, including the trial’s sample-size justification, a statistical analysis plan, and any multiplicity approach. The record marks masking as none and does not describe a randomized allocation. The safety reporting period and event details are also not specified. These limitations concern what can be learned from the registry record and do not establish what may have been documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Wear Experience With a Daily Disposable Contact Lens — NCT04296877.
- Registry record last updated 2023-03-07; status last verified 2023-03.
- Results first posted 2023-03-07.
- 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 describes a completed, single-group, non-comparative study sponsored by Ohio State University. Enrollment is listed as 30. The study began on 2020-03-10, had a primary completion date of 2020-12-01, and is marked completed. Participants were current two-week lens wearers fit into daily disposable contact lenses and asked to wear them for two weeks.
The primary outcome was the CLDEQ-8 survey at 2 weeks. The record describes its 0 to 37 scale, with higher scores indicating worse dry-eye symptoms, and specifies the median and inter-quartile range as summaries. The observed outcome and analysis are not reported in the registry record.
The safety record lists 30 participants at risk, zero serious adverse events, zero other adverse events, and zero deaths. The record lists no analyses.