ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1® (NCT02750813), a randomized na study. The primary outcome is Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14.

2. Clinical Question

3. Trial Design

The registry identifies NCT02750813 as a randomized, double-masked, crossover device study. Its official title describes a clinical comparison of ACUVUE® OASYS® 1-DAY and DAILIES TOTAL1® in a symptomatic population. The listed condition is refractive error, and the phase is recorded as NA. The sponsor is Alcon, a Novartis Company. The record lists enrollment of 252 and a completed status.

Participants followed one of two product sequences. In one sequence, delefilcon A contact lenses were worn first and senofilcon A lenses followed; in the other, senofilcon A lenses came first and delefilcon A lenses followed. Each product was worn in both eyes for 14 days, with daily wear and daily replacement. The primary outcome was assessed at Day 14 for each product. The registry dates are 2016-04-27 for study start and 2016-08-17 for primary completion.

A crossover design lets each participant experience both products, so the product periods are not automatically equivalent to independent parallel groups. The order of exposure can matter to interpretation, and paired analyses can account for within-participant relationships. However, the registry record does not report whether a washout was used, how period or sequence effects were assessed, or which statistical approach was used for the primary outcome. Randomization and double masking are recorded, but the record does not give further details about the randomization procedure or masking implementation.

The outcome summaries list 244 eyes analyzed for each product. The record defines the primary analysis population as the Full Analysis Set and says the number analyzed is the number of eyes with a non-missing response. This eye-level description matters because both eyes contributed to the percentage, and eyes from the same participant may be statistically related. The registry does not report how that relationship was handled in the primary analysis.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).

Period 1, First 14 Days of Wear

Reasons for not completing this period:

Period 2, Second 14 Days of Wear

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

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: This analysis population includes all randomized subjects who were exposed to any study lens, except for lenses used at Visit 1 for parameter optimization and fitting (Full Analysis Set).

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14, measured over Day 14, each product.

The primary endpoint is the percentage of lenses graded 0 or 1 for centration at Day 14 for each product. An investigator assessed centration separately for each eye using a five-point scale: 0 for centered or optimal, 1 for slight decentration, 2 for mild decentration, 3 for moderate decentration, and 4 for severe decentration. The reported percentage combines the first two grades. Lenses from both eyes contributed.

This endpoint describes how lens position was graded during the study. Combining grades 0 and 1 creates a summary focused on lenses assessed as centered or only slightly decentered, rather than preserving the full range of grades. It is a measure of lens fit characteristics, consistent with the study purpose stated in the registry. The record does not report a threshold for a clinically important difference, nor does it explain how a change in this percentage would relate to symptoms or other outcomes.

The posted percentages are 100.0% for DAILIES TOTAL1® and 99.4% for ACUVUE® OASYS® 1-DAY, with 244 eyes analyzed for each product. These are descriptive summaries. The registry record does not report a confidence interval, p-value, or sponsor-reported inferential comparison for the primary endpoint. The percentages therefore describe the observed grades but do not, on their own, quantify the precision of a between-product difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Several statistical ideas help explain what can and cannot be concluded from these results. The primary endpoint is a proportion: it counts lenses receiving either of the two designated grades and expresses that count as a percentage of the lenses assessed. A percentage is easy to interpret descriptively, but a comparison between percentages also needs an estimate of uncertainty. A confidence interval is one way to show the range of values compatible with the data under the analysis assumptions. No confidence interval for the primary outcome is reported in the registry record.

The study used a crossover design, in which participants received both products in a specified order. In general, observations from the same participant are related rather than independent. A crossover analysis may use within-participant comparisons and can consider whether results differ by period or sequence. These are general features of crossover analysis, not a description of the analysis used in this trial. The registry record does not report the primary statistical model, how order or period was handled, or whether a washout was used. The reported product-level percentages alone do not reveal whether the analysis accounted for the paired structure.

The endpoint also includes observations from both eyes. In general, two eyes from one participant may be more alike than eyes from different participants. Treating all eyes as independent can make uncertainty appear smaller than it is when that relationship is not addressed. This is a general statistical consideration; the record does not say whether the primary analysis modeled the relationship between eyes or how it combined eye-level observations. The reported number analyzed refers to eyes with non-missing responses, not a reported number of participants in each product summary.

The secondary outcome is continuous and is reported as a mean with a standard deviation for each product. A mean describes the center of the observed measurements, while a standard deviation describes their spread. The posted comparison is labeled as a mean difference and includes a confidence interval. The interval gives a range of estimates compatible with the summary data under the assumptions of the recalculation. The p-value, p < 0.001, is an unadjusted measure of how inconsistent the data are with a specified no-difference model under the calculation assumptions; it is not the probability that the no-difference model is true.

The secondary comparison is a recalculation from posted summary statistics, rather than a listed sponsor-reported analysis. The record marks no discrepancy between the recalculated result and a sponsor result, but it also lists no reported analyses for this outcome. The recalculation is unadjusted, and it should not be interpreted as incorporating covariates, crossover pairing, or other design features unless those are specifically stated. The record does not state those details. In general, a confidence interval and p-value computed from summary statistics can be useful for orientation, but they cannot replace a fully described analysis of the original study data.

Multiplicity refers to the statistical complications that arise when several outcomes or comparisons are examined. With multiple opportunities to find an apparently notable result, an unadjusted p-value can overstate the strength of evidence if interpreted as though it were the only planned test. The record lists two outcome measures and one secondary outcome, but does not report a multiplicity plan or adjustment. This does not establish that no plan existed; it means the plan is not reported in the registry record. For that reason, the unadjusted secondary result deserves more caution than a result from a clearly specified primary analysis with a reported multiplicity strategy.

The sample-size planning illustration for the secondary comparison is based on the observed effect, not on the trial's own design. It uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration gives participants per arm for 80% and 90% power when planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The corresponding reported values are 2 and 2; 3 and 3; and 5 and 7. These are planning illustrations, not observed power and not evidence that the trial was designed to detect those effects. The registry record does not report the original sample-size justification.

Power is a property of a proposed study under assumptions about the effect, variability, allocation, and analysis. It is not a measure of how likely a result is to be true after the study has been completed. Planning calculations based on an observed effect can be especially optimistic when that effect is uncertain. The listed illustrations are therefore best understood as hypothetical design aids under the stated assumptions, not as a retrospective assessment of whether the study was adequately powered.

Finally, missingness and analysis populations affect interpretation. The primary analysis set is described as the Full Analysis Set, with the number analyzed defined as eyes having a non-missing response. The record does not report reasons for missing responses, how missing outcomes were handled, or whether any sensitivity analyses were conducted. Those details are important because the observed summaries may represent only the eyes with available assessments. The posted information supports a description of the available results, but not an assessment of how missing data may have influenced them.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary centration outcome and a secondary ex vivo friction outcome. It does not report a statistical analysis plan, a multiplicity adjustment, or how outcomes were prioritized for formal inference. When several outcomes are considered, unadjusted p-values may provide weaker evidence than a result interpreted within a prespecified multiplicity strategy. The absence of a reported strategy should be treated as missing information, not as proof that no strategy was used.

For the primary outcome, the analysis population is called the Full Analysis Set. The record defines the number analyzed as the number of eyes with a non-missing response. The posted product summaries each include 244 eyes. The record does not explain how the Full Analysis Set was defined beyond that description, how missing responses were treated, or whether analyses were conducted in other populations.

Enrollment is listed as 252, while the product-specific safety groups list 246 at risk. These figures refer to different registry summaries and should not be assumed to represent the same analysis set or outcome denominator. The record does not give reasons for missing primary responses or explain the difference between the counts. No missing-data sensitivity analysis is reported.

Both eyes contributed to the primary percentage, but the registry record does not report whether the analysis accounted for correlation between eyes. It also does not report whether the crossover analysis accounted for within-participant pairing, sequence, or period. Such details matter for estimating uncertainty and interpreting a product comparison. The available record does not permit readers to assess whether these design features were addressed in the primary analysis.

The secondary comparison is an unadjusted recalculation, and the registry lists no sponsor-reported analyses for it. The record does not specify whether any adjustment for multiple outcomes was planned or applied. Taken together, the unreported analysis details limit evaluation of both the primary comparison's precision and the secondary result's inferential weight.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry reports zero serious adverse events, zero other adverse events, and zero deaths in each listed group. The pretreatment group lists 252 at risk; the DAILIES TOTAL1® and ACUVUE® OASYS® 1-DAY groups each list 246 at risk. No serious adverse event terms are listed.

These figures describe the events recorded in the registry for the listed groups. They do not show that the products are free of risk, and they do not establish that the products have equivalent safety. A group with zero recorded events can still have uncertainty about the underlying frequency of events, particularly when the observation period and size of the safety population are limited. The registry record does not provide event narratives, exposure-adjusted rates, or additional details about how adverse events were collected.

The study involved product periods of 14 days each, but the safety record does not state the timing of each event assessment or provide a fuller account of follow-up for safety. The posted zero counts should therefore be read narrowly as the recorded event counts, not as a general safety conclusion.

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

The primary result describes the percentage of assessed lenses that investigators graded as centered or slightly decentered at Day 14. The posted summaries report 100.0% for DAILIES TOTAL1® and 99.4% for ACUVUE® OASYS® 1-DAY. Those values provide a direct description of the observed classifications in the analyzed eyes.

The record does not report an inferential comparison or uncertainty interval for the primary outcome. As a result, the percentages alone cannot establish how precisely the products differ on this measure. They also cannot show whether any difference is clinically important, because the registry does not report a threshold for clinical importance or a relationship between these grades and participant symptoms.

The study's crossover design and use of both eyes are relevant to statistical interpretation. Without details about how the analysis accounted for product order, repeated measurements, and relationships between eyes, the precision of a comparison cannot be independently evaluated from the posted summaries. The lack of those details is not proof that the analysis was inappropriate; it limits what can be assessed from the registry record.

The secondary ex vivo measure has its own posted comparison, but it addresses a different outcome and does not fill the primary endpoint's reporting gaps. It should not be taken as a direct measure of centration, symptoms, or overall product performance. Likewise, the zero adverse-event counts are limited to events recorded for the listed groups and do not establish absence of risk.

In general, statistical results describe evidence under particular measurements, populations, and analysis assumptions. They do not by themselves determine what an individual should use or provide medical advice. The registry record supports a narrow account of the reported lens-centration grades and the separate ex vivo measurement, while leaving important questions about precision, clinical relevance, and analysis methods unresolved.

13. Why This Trial Matters Statistically

This trial is statistically interesting because its design and endpoint create several interpretation issues at once. It is a randomized crossover study, so product order and within-participant comparisons can matter. The primary outcome includes both eyes, which raises a separate question about the relationship between observations from the same participant. The registry record does not report how the primary analysis addressed either feature.

The primary outcome is reported as product-level percentages, but no confidence interval or inferential comparison accompanies those values. This makes the distinction between a descriptive result and an estimate of a product difference especially important. Readers can see the observed proportions, but cannot use the posted primary statistics to judge the precision of a comparison.

The secondary endpoint illustrates another statistical distinction: a result can have a reported unadjusted interval and p-value without being a substitute for a fully reported primary analysis. Its ex vivo measurement, smaller number of observations, and lack of a reported multiplicity plan all affect how much weight it can carry. The registry also lists planning illustrations based on the observed effect, which are hypothetical design calculations rather than observed power or evidence about the original study design.

Finally, enrollment, analyzed eyes, and safety denominators are not identical quantities. Reading them in context prevents an eye-level outcome count from being mistaken for a participant count, or safety counts from being treated as the primary analysis population. These distinctions are broadly useful when evaluating registry results: the endpoint, unit of analysis, design, uncertainty, and analysis population all shape what a number means.

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.

Several limitations specific to this record constrain interpretation. The primary outcome is an investigator-assessed grade summarized as the combined percentage for grades 0 and 1. The registry describes the scale but does not report details about assessor training, agreement between assessors, or whether grading was independently verified. The record also gives no threshold for a clinically important difference or reported relationship between centration grades and symptoms.

The primary results are descriptive percentages without a confidence interval or inferential comparison. Although the study used a crossover design and both eyes contributed, the record does not describe how the analysis accounted for paired observations, product order, period effects, or correlation between eyes. It does not report whether washout was used. These omissions limit assessment of the comparison, but do not establish that these factors were ignored in the study's actual analysis.

The record defines the primary analysis set as the Full Analysis Set and the analyzed count as eyes with non-missing responses. It does not explain missingness, give reasons for unavailable responses, or report sensitivity analyses. The safety group counts are also distinct from the primary endpoint counts, and the record does not explain the difference.

The secondary endpoint is an ex vivo measure with 17 observations for each product. Its comparison is an unadjusted recalculation, with no sponsor-reported analysis listed and no reported multiplicity plan. It therefore has limited ability to support broader conclusions. The study periods lasted 14 days for each product, so the registry results describe short-term assessments rather than longer-term outcomes. The record does not report longer follow-up.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1® — NCT02750813.
• Registry record last updated 2018-07-02; status last verified 2017-08.
• Results first posted 2017-09-26.
• 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.

18. Record Summary

NCT02750813 is a completed randomized, double-masked crossover device study sponsored by Alcon, a Novartis Company. The registry lists enrollment of 252, refractive error, and a symptomatic population in the official title. Study start is recorded as 2016-04-27 and primary completion as 2016-08-17.

Participants wore DAILIES TOTAL1® and ACUVUE® OASYS® 1-DAY in opposite sequences, with each product worn bilaterally for 14 days. The primary endpoint was the percentage of lenses graded 0 or 1 for centration at Day 14. The posted percentages were 100.0% and 99.4%, respectively, with 244 eyes analyzed for each product. The registry does not report an inferential comparison for this endpoint.

One secondary outcome, Ex Vivo Critical Coefficient of Friction at Day 14, is reported. Safety summaries list zero serious adverse events, zero other adverse events, and zero deaths in each group. Statistical analysis details, missing-data handling, and a multiplicity plan are not reported in the registry record.