Multicenter Dispensing Study of Biofinity Lenses in Extended Range: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multicenter Dispensing Study of Biofinity Lenses in Extended Range (NCT02060539), a na na study. The primary outcome is Dryness (During Day and Dryness at Night).

2. Clinical Question

The broad study question was whether existing contact lens wearers would provide subjective and objective feedback on Biofinity XR after daily wear, with their habitual lenses serving as a reference point. Such feedback can include a participant's experience as well as observed lens characteristics. The registry lists secondary outcomes concerning lens centration, lens movement, and overall fit acceptance.

The distinction between the broad objective and the registered primary measure matters. The primary measure is explicitly assigned a baseline timeframe, and its description says the habitual lens history was obtained at baseline. It therefore characterizes the participants' reported dryness with their habitual lenses at that assessment; it is not, by itself, a measurement of dryness after Biofinity XR wear. The registry record does not report a result comparing dryness after wear with baseline or with habitual lenses.

The record does not report additional detail on eligibility criteria, the participants' prior lens-wearing history, or the specific population represented beyond existing contact lens wearers and the listed conditions. Those details are not reported in the registry record.

3. Trial Design

The registry identifies this as a completed, multicenter dispensing study of Biofinity lenses in an extended range. It lists a single-group model, no masking, and allocation as NA. The record lists enrollment of 19. It does not describe a randomized allocation process or a separate concurrent control arm. The habitual lenses appear as the reference for feedback in the study summary, rather than as a parallel study group.

Participants were dispensed Biofinity XR lenses over two weeks of lens wear. The brief summary describes the intended feedback period as at least two weeks of daily wear. The record lists the study start as 2013-10 and primary completion as 2014-04, with status completed. The phase is listed as NA. CooperVision, Inc. is identified as the sponsor.

The registry lists 42 outcome measures and 0 analyses. The primary outcome is dryness during the day and at night, measured at baseline on a visual analog scale. The other listed outcomes include lens centration, lens movement, and overall fit acceptance, including outcomes referring to habitual lenses. The record does not give numerical results for these measures in the registry record for this analysis.

A single-group dispensing design can describe participant experience and observed fit during use, but it does not create the same basis for comparison as a randomized trial with a concurrent control group. Assessments against habitual lenses may be informative as within-participant context, but the record does not report enough detail to establish how such comparisons were conducted or analyzed. Masking is listed as none. Further information about assessment procedures, visit schedules, outcome definitions beyond the listed descriptions, and the statistical analysis plan is 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

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.

6. Primary Endpoint

The registry lists the primary outcome as Dryness (During Day and Dryness at Night), measured over Baseline.

The registered primary endpoint is dryness during the day and dryness at night. It is a continuous measure reported as a mean with standard deviation, in units on a scale. The description identifies a participant questionnaire using a visual analog scale from 0-100. A score of 0 is defined as cannot be worn and extremely dry; a score of 100 is defined as no dryness experienced at any time. The assessment timeframe is baseline, with habitual lens history obtained at that assessment.

In general, a continuous symptom scale can represent gradations of a subjective experience rather than forcing responses into broad categories. A mean describes the average recorded response, while the standard deviation describes variation in responses around that mean. These summaries can help readers understand both the group-level reported experience and how varied individual responses were. They do not show the full distribution of responses or explain why participants differed.

Dryness is relevant to a study soliciting subjective feedback on contact lens performance because it captures a wearer-reported aspect of experience. However, the baseline timing limits what this endpoint can establish about Biofinity XR. As registered, it describes dryness associated with habitual lens history at baseline; it does not directly quantify dryness following the dispensing period. No mean, standard deviation, or other primary outcome estimate is reported in the registry record, so the level or variability of baseline dryness cannot be described from the registry entries.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods help connect a research question to a clearly defined measurement and an appropriate comparison. In this study, the registry record identifies a continuous primary outcome, gives its scale and baseline timeframe, and describes the trial as single-group. It does not report outcome estimates or analyses. General statistical concepts can clarify what the listed measurement and planning assumptions mean, but they cannot replace the absent results.

What does a mean with standard deviation describe?

For a continuous measure, the mean is the arithmetic average of recorded values. It gives a compact description of the group's central response, but it does not imply that every participant had a response near that average. The standard deviation describes the spread of individual values around the mean. A larger standard deviation indicates more variation in responses; a smaller one indicates that responses are more clustered. Neither summary identifies the shape of the full response distribution, and neither reveals whether an individual participant improved or worsened.

The primary measure is a questionnaire response on a visual analog scale, described as running from 0-100. Its endpoints have stated interpretations related to wearability and dryness. In general, a scale can make a subjective experience easier to summarize consistently, but interpretation depends on clear administration and a meaningful assessment time. The record specifies baseline and habitual lens history for this endpoint. It does not report the actual mean or standard deviation, so the observed level and spread cannot be evaluated.

What would a comparison need to establish?

A comparison requires outcomes measured in a way that supports the intended contrast. The summary frames the study objective as feedback after at least two weeks of daily wear compared with habitual lenses. The primary outcome, however, is assigned a baseline timeframe and describes habitual lens history. The record does not provide a post-wear primary estimate, a change score, or details of a formal within-participant comparison. It is therefore not possible to infer a treatment contrast from the listed primary measure.

In general, a randomized concurrent control group helps separate the intervention contrast from other changes over time by making groups comparable on average at the outset. This study is described as single-group, and allocation is NA. Its design does not include a separate randomized control group in the registry entries. Comparisons with habitual lens experience may offer context, but interpretation depends on how those assessments were timed, collected, and analyzed. Those details are not reported in the registry record.

How should precision be judged?

A confidence interval is a statistical range associated with an estimate under specified assumptions. It communicates how precisely an effect has been estimated and which values remain compatible with the data and method. It does not guarantee that the true effect lies within the interval, nor does it remove potential bias in the design or measurement. No outcome estimate or confidence interval is reported in the registry entries used. Precision of the primary outcome therefore cannot be assessed.

A p-value, in general, describes how unusual data at least as incompatible with a null hypothesis would be under that hypothesis and the model assumptions. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The record does not report a p-value or an analysis for the outcome details. Statistical significance cannot be inferred from the study objective, design description, or safety counts.

What do the planning assumptions mean?

The planning description identifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. In general, a sample-size calculation uses assumptions about the effect size, variability, error rate, allocation, and analysis method to estimate how many participants would be needed under a proposed design. Changing those assumptions changes the planning result.

Those assumptions do not describe the actual study design in the registry, which is listed as single-group. The planning description is expressly an illustration based on an observed effect, not the trial's own design. The numerical observed effect and the numerical illustration results are not reported in the registry record details. Planning values should therefore be read as hypothetical design scenarios, not as findings about the participants or as observed power. The record does not report a sample-size justification for the actual study.

The planning note distinguishes time-to-event illustrations, which use total events under the Schoenfeld method, from other illustrations, which give participants per arm. That convention concerns how planning quantities are expressed; it does not establish that this trial used a time-to-event endpoint. The listed primary outcome is continuous, and no time-to-event primary measure is described in the registry record.

What cannot be assessed from the registry entries?

The registry lists 42 outcome measures and 0 analyses, but does not provide numerical outcome summaries in the registry entries. It does not report an analysis model, covariate adjustment, confidence intervals, p-values, handling of missing observations, or analysis populations. Those omissions prevent a reader from checking model assumptions, judging precision, or understanding which participants contributed to a particular outcome analysis. They also prevent assessment of whether the analysis followed a prespecified plan. These items are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 42 outcome measures, spanning the primary dryness measure and outcomes such as lens centration, lens movement, and overall fit acceptance. When a study evaluates many outcomes, there can be multiple opportunities to observe apparently notable results by chance. In general, a prespecified hierarchy, multiplicity adjustment, or carefully qualified interpretation can help readers understand the status of multiple comparisons. The registry entries do not report a multiplicity strategy or a statistical analysis plan, so it is not possible to tell whether any such approach was planned or used.

The record lists 0 analyses. It does not provide numerical results for the listed outcomes in the registry record. Without reported estimates and analysis details, the effect of multiple testing on interpretation cannot be evaluated. The list of outcomes alone should not be read as evidence that each was analyzed or that any met a threshold for statistical significance.

Missing-data handling is also not reported in the registry record. The registry entries do not describe the number of completed assessments, missing responses, reasons for missingness, or methods used to address missing data. In general, missing observations can affect both the estimate and its precision, especially if the chance of a measurement being missing is related to a participant's experience. No assumption about missingness or imputation method can be made from the registry entries.

Analysis populations are not reported in the registry record. The registry entries do not identify whether analyses included all enrolled participants, only those who completed lens wear, or another defined group. The listed enrollment of 19 does not establish the number contributing data to any particular outcome. These reporting gaps limit reproducibility and make it difficult to connect any hypothetical analysis to the enrolled group.

11. Safety Results

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

Other (non-serious) adverse events

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

The safety record lists a group labeled Comfilcon A, with 19 participants at risk for serious adverse events and 0 affected. It also lists 19 at risk for other adverse events and 0 affected. These are event counts as recorded, not estimates of risk in a broader population. The record does not report a death count; that information is not reported in the registry record. No top serious adverse event terms are listed.

Zero reported events in this group means that the registry lists no affected participants for these categories during the recorded study period. It does not establish that an event is impossible or that the risk is absent in other settings. In general, safety counts describe what was observed and recorded in the study; their interpretation depends on the duration and completeness of follow-up, definitions, and reporting procedures. Those details are not reported in the registry record.

The intervention is named Biofinity XR, while the safety group is labeled Comfilcon A. The record details do not explain the relationship between those labels, so they should not be assumed to be interchangeable. The safety counts also do not describe the primary dryness endpoint or demonstrate a comparative safety effect, since a separate control group is not described.

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

The registry record establishes that a completed, multicenter, single-group dispensing study was conducted to collect subjective and objective feedback on Biofinity XR after a period of daily wear. It identifies existing contact lens wearers with myopia or hyperopia, an enrollment of 19, and several outcome domains. It also gives a baseline definition for the primary dryness measure. These registry entries describe the study's purpose and framework; they are not outcome findings.

The primary endpoint is assigned to baseline and refers to habitual lens history. Without a reported post-wear value or a documented comparison, it cannot show whether dryness changed during Biofinity XR wear. The record does not report the primary outcome mean, standard deviation, confidence interval, p-value, or analysis. It therefore does not establish the size, direction, or precision of a dryness response.

The secondary outcome list indicates that the study considered fit-related observations and acceptance. The registry entries do not report numerical results for those outcomes. Their presence in the outcome list cannot be taken as evidence of favorable or unfavorable fit, or as evidence that a specific result was statistically significant.

The design also affects what can be inferred. A single-group study without masking and without a separate randomized control group can provide descriptive experience and observations, but it does not support the same causal comparisons as a randomized controlled design. Habitual lens experience is described as a reference, yet the record does not report the method or results of a formal comparison. Potential changes over time cannot be attributed to the dispensed lenses from these registry entries alone.

The reported safety counts are limited to the registry's listed group and categories. They should not be generalized beyond the recorded study, and the relationship of the Comfilcon A safety label to the named intervention is not explained. In short, the registry record documents the study and selected safety counts, but does not report the outcome analyses needed to determine what participants experienced after wear or how precisely any effect was estimated.

13. Why This Trial Matters Statistically

This study illustrates why a research objective, a registered endpoint, and a reported result need to be read separately. The broad objective concerns feedback after daily wear and comparison with habitual lenses. The listed primary dryness endpoint is a baseline measure of habitual lens history. Recognizing that timing distinction prevents a baseline description from being mistaken for evidence about a later response.

The design also illustrates the difference between a reference experience and a concurrent control group. Habitual lenses give context for the study's question, but the registry describes a single-group study and does not report a formal comparison analysis. Statistical interpretation depends not only on what is being compared, but also on when and how measurements were collected and what analysis was planned.

Another statistical lesson is that outcome registration does not itself convey findings. Although the record lists 42 outcome measures, it lists 0 analyses in the registry record and does not provide numerical endpoint results. Without estimates and measures of precision, readers cannot evaluate the magnitude or uncertainty of outcomes, nor can they assess whether findings across multiple outcomes were handled with an appropriate multiplicity strategy.

Finally, planning calculations and observed results answer different questions. The registry's planning description outlines assumptions for hypothetical two-arm calculations, while the study is listed as single-group. Such illustrations can inform future design choices when their inputs and results are available, but they do not establish the study's observed effect or power. Keeping these distinctions clear supports cautious, reproducible interpretation of clinical evidence.

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 restrict interpretation. The study is listed as single-group, with no masking and allocation NA. The record does not describe a separate randomized control group. This limits the basis for attributing any observed changes to the dispensed lenses rather than to time, expectations, measurement conditions, or other influences. The study summary mentions habitual lenses as a reference, but the registry entries do not report a formal comparison method.

The timing of the primary outcome is another important limitation. Dryness is registered at baseline, and the description specifies habitual lens history. The broad study objective concerns feedback after at least two weeks of daily wear, but no post-wear dryness result is reported in the registry record. This leaves the primary endpoint unable to address a change after lens dispensing on its own.

The record lists 42 outcome measures and 0 analyses. No numerical outcome summaries, statistical estimates, or precision measures are reported in the registry record. Analysis populations, missing-data procedures, multiplicity handling, and the statistical analysis plan are not reported in the registry record. Without these details, readers cannot evaluate how the outcomes were analyzed, whether all enrolled participants contributed to each measure, or how uncertainty and multiple comparisons were addressed.

The safety group is labeled Comfilcon A, while the intervention is named Biofinity XR; the relationship between those labels is not explained. The registry entries also do not provide detailed eligibility criteria, assessment schedules, or follow-up completeness. These reporting limitations mean that the results cannot be independently reconstructed or generalized beyond the study description and recorded safety counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Multicenter Dispensing Study of Biofinity Lenses in Extended Range — NCT02060539.
• Registry record last updated 2017-12-11; status last verified 2015-06.
• Results first posted 2015-06-30.
• 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

The registry identifies NCT02060539 as a completed, multicenter, single-group dispensing study sponsored by CooperVision, Inc. It lists Biofinity XR as the intervention, enrollment of 19, and existing contact lens wearers with myopia or hyperopia as the study context. Participants were dispensed lenses over two weeks of wear; the summary describes feedback after at least two weeks of daily wear. The record lists no masking and allocation as NA.

The primary outcome is dryness during the day and at night, measured at baseline by questionnaire about habitual lens history on a visual analog scale from 0-100. The record lists 42 outcome measures and 0 analyses. Numerical results for the primary endpoint and other outcomes are not reported in the registry entries. Safety listings record 0 serious and 0 other adverse events among 19 at risk in the group labeled Comfilcon A; a death count is not reported in the registry record.