Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses (NCT02185105), a randomized na study. The primary outcome is Lens Surface Assessment of Study Lenses - Surface Wettability.

2. Clinical Question

The registry states a broader hypothesis: there is no difference in clinical performance between the test and control lenses. It names lens stability, toric mislocation, comfort ratings, and anterior segment ocular health findings as areas of interest. The primary outcome named in the record is narrower: an investigator’s objective assessment of lens surface wettability.

The question is framed as a comparison, but the registry record does not report the numerical wettability results, an estimated difference, or an uncertainty interval. It therefore does not establish whether the observed assessments were similar or different, nor how precisely any comparison was estimated. The record also gives no threshold defining what size of difference would be clinically important. Without such a threshold, a general statement of no difference cannot be interpreted as a formal demonstration of equivalence.

The time points are specified as 15min and 6hrs. The record does not explain whether the intended comparison was separate at each time point, combined across time points, or based on another summary. The endpoint has a scale from 0 to 4, where 0 means non-wetting and 4 means Excellent. These scale anchors describe what the values mean, but do not supply actual participant assessments or group averages.

3. Trial Design

The study is titled Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses. The registry identifies CooperVision, Inc. as the sponsor and lists the conditions as myopia and astigmatism. The study status is completed. Its recorded start and primary completion are both 2014-06.

The registry classifies the design as randomized, single-masked, and parallel. Enrollment is 30. The two named devices are comfilcon A MTO and comfilcon A. The arm descriptions say subjects would be randomized to receive either the test or control lens as a matched pair at each visit, according to a predetermined randomization schedule. That description is reported as written; the registry does not further clarify how the matched-pair language relates to its parallel-design classification or how lens exposure was organized across visits.

Single masking means that the record identifies one masking level, but it does not name the people or roles who were masked. That information is not reported in the registry record. The record also does not give details of the randomization sequence, allocation concealment, visit schedule beyond the primary endpoint time points, or the duration of participant follow-up.

The record lists the study phase as NA. It gives 19 outcome measures, but reports zero statistical analyses. The enrollment figure describes the study as registered; it should not be confused with outcome-specific counts or with the number of observations available at every time point. The adverse-event entries list 30 participants at risk in each lens group, but the record does not provide a participant flow account that links those entries to endpoint data.

Several design details needed to reconstruct the conduct of the comparison are not reported in the registry record. These include the precise eligibility criteria, the masking roles, the method used to generate the allocation schedule, the handling of visits or measurements that were not completed, and the analysis population. They should not be inferred from the design labels alone.

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 Lens Surface Assessment of Study Lenses - Surface Wettability, measured over 15min & 6hrs.

The primary endpoint is titled Lens Surface Assessment of Study Lenses - Surface Wettability. It is described as an investigator’s objective assessment at 15min and 6hrs, reported as a mean with standard deviation and measured in units on a scale. The scale ranges from 0 to 4: 0 is non-wetting and 4 is Excellent.

In general, a scale assessment gives a structured way to characterize a feature rather than relying only on an unstructured narrative. Wettability is a lens-surface property, so assessing it can contribute information about the lens as worn. An objective assessment is intended to make the rating less dependent on subjective impression, although the registry record does not explain the assessment procedure, training, repeatability, or safeguards against observer influence.

The two specified time points allow assessment at different moments after lens placement. In general, observations at distinct times can address whether an endpoint varies over time, but the registry does not state how the time points were to be compared statistically. Nor does it identify a single summary across them. The outcome is therefore not reducible to one reported result based on the information in the registry record.

No group means, standard deviations, participant-level values, comparison estimates, or confidence intervals for wettability are reported in the registry record. The scale definition tells readers how to interpret possible scores; it does not indicate what scores participants received or whether the test and control assessments differed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, single-masked, parallel study. Those labels provide a broad outline of the design, not a full statistical analysis plan. Randomization is generally used to reduce systematic differences between assigned groups, while masking is generally intended to limit the influence of knowledge about assignment on study conduct or assessment. The record does not identify who was masked, how the allocation schedule was generated, or what procedures were used to conceal assignments. The arm descriptions refer to matched pairs at each visit, while the design classification is parallel; the relationship between those descriptions is not explained.

What does the reported outcome summary mean?

The primary outcome is continuous in the registry’s classification and is described using a mean and standard deviation. In general, a mean is the arithmetic average of the observed scores. A standard deviation describes how spread out scores are around that average. It is not the same as the uncertainty in the estimated mean, and it does not by itself show whether groups differ. Since the record gives no group means or standard deviations, these summaries cannot be interpreted for this comparison.

The endpoint is measured on a 0-to-4 scale and has two stated assessment times, 15min and 6hrs. The scale anchors identify the meaning of the endpoints, from non-wetting to Excellent. The record does not describe how intermediate values were assigned, whether assessors could use fractional values, or how missing assessments were treated. It also does not provide the observations needed to understand the distribution of scores.

How should a comparison estimate be read?

In general, a comparison estimate describes the difference between groups according to a specified statistical method. Its meaning depends on the selected scale, time point, analysis population, and model. A confidence interval gives a range of values compatible with the data and the method’s assumptions; it helps express precision. A narrow interval indicates greater precision than a wide interval, but whether the values in the interval matter clinically depends on a relevant threshold. No comparison estimate or confidence interval for wettability is reported in the registry record.

A p-value, when used, summarizes how compatible the data are with a specified null hypothesis under a statistical model. It does not quantify the size or importance of a difference, and it does not establish equivalence. The registry does not report a p-value or the statistical test used for the primary endpoint. It is therefore not possible to identify the analysis model, its assumptions, or whether any adjustment was made.

Why do the time points and other outcomes matter?

In general, assessing multiple outcomes or time points can create multiple opportunities to observe apparently notable findings. A statistical plan may address this through a prespecified hierarchy, adjustment, or a clear distinction between primary and exploratory comparisons. The registry lists 19 outcome measures, but does not report a multiplicity strategy or statistical analyses. It does not describe whether the two wettability assessments were separate primary comparisons or part of a joint analysis.

Measurements from the same participant can be related rather than independent. In general, an analysis of repeated or paired measurements may need to account for that relationship. The registry’s arm descriptions mention matched pairs at each visit, but the statistical method for handling observations across lenses, visits, or time points is not reported. No particular repeated-measures or paired analysis should be assumed.

What do the planning assumptions say?

The registry record describes sample-size illustrations as planning calculations based on the observed effect, rather than the trial’s own design justification. It states assumptions of a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It also says that time-to-event illustrations use total events and other illustrations use participants per arm. These are calculation assumptions, not evidence that the trial was planned with those assumptions or that a particular sample size was adequate.

Planning calculations are not observed power. In general, an illustration of sample size under chosen assumptions does not describe the probability that the completed study produced a significant result, and it cannot substitute for an estimate with an uncertainty interval. The record does not provide the numerical observed effect or planning counts in the registry record for this account. The primary endpoint is also identified as having multiple categories or time points and not being reduced to one comparison, which limits interpretation as a single effect.

What statistical details remain unknown?

The analysis population, missing-data methods, treatment of protocol deviations, model specification, covariates, handling of repeated observations, and rules for interpreting the scale are not reported in the registry record. The number of analyses is recorded as zero. These omissions mean that the statistical procedure used to produce any underlying study conclusion cannot be reconstructed from the registry entry. General statistical principles can explain what these methods would address, but they cannot determine which methods were actually used.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures and identifies wettability at 15min and 6hrs as the primary endpoint. It does not explain the planned hierarchy among outcomes, whether the two time points were treated as separate comparisons, or how multiplicity was addressed. The number of listed outcomes does not reveal how many statistical tests were conducted. The registry reports zero analyses, and no multiplicity procedure is reported in the registry record.

In general, multiplicity matters when several comparisons are examined because the chance of at least one apparently notable result can increase as more comparisons are considered. A prespecified strategy may control that issue or clarify which comparisons are confirmatory and which are exploratory. No such strategy can be attributed to this study from the registry information.

Missing-data methods are also not reported. The record does not state how many participants contributed measurements at each assessment time, whether any observations were unavailable, or how incomplete data were handled. The enrollment figure is not a substitute for outcome-specific denominators.

The analysis population is not reported in the registry record. It is not possible to tell whether the intended analysis included all randomized participants, only those with measurements, or another defined group. The registry does not report exclusions, protocol deviations, or an analysis plan for handling them. These unknowns limit interpretation of any conclusion beyond the descriptive design information that is posted.

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 adverse-event entries list Comfilcon A MTO and Comfilcon A, with 30 participants at risk in each group. The registry records zero participants affected by serious adverse events and zero affected by other adverse events in each group. These figures describe what is recorded in the registry; they do not provide event terms, event timing, or a detailed account of how events were collected.

The death fields are null, so deaths are not reported in the registry record. A null entry is not the same as a reported count of zero. The record also does not state the safety-reporting period or explain whether the at-risk counts cover the same time window for both groups.

In general, a count of zero reported events does not prove that no event could occur. Interpretation depends on the duration and completeness of observation, how events were defined and solicited, and whether all relevant events were entered. Those details are not reported in the registry record. The adverse-event figures should therefore be read as registry entries, not as a complete characterization of safety or as a comparison demonstrating a difference between lenses.

The listed at-risk counts are not an outcome analysis and do not establish that every enrolled participant contributed to every safety or efficacy measure. The record provides no safety comparison estimate or uncertainty interval. It also does not identify specific serious adverse-event terms; no top serious terms are listed.

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

The registry record establishes that a completed randomized, single-masked study compared comfilcon A MTO with comfilcon A, with wettability identified as the primary endpoint. It describes the endpoint scale and its assessment times, and records adverse-event counts for the two groups. These details help define the question the study was intended to address.

The record does not report numerical results for the primary outcome or statistical analyses. It therefore cannot show the direction or size of any difference, the variability of the assessments, or the precision of a comparison. It cannot establish that the lenses performed similarly, that one performed better on the primary endpoint, or that any observed distinction would be meaningful. The stated no-difference hypothesis is not itself evidence that the hypothesis was supported.

In general, a conclusion of equivalence requires more than a nonsignificant difference. It depends on a defined margin for an acceptable difference and an analysis that evaluates the estimate against that margin. The registry record does not report an equivalence margin or a formal equivalence analysis. No equivalence conclusion should be inferred from the study title or hypothesis.

The safety entries show zero affected participants for the recorded serious and other adverse-event categories in each group, with deaths not reported. They do not establish the absence of risk or describe the full safety experience, because the registry does not report the observation period or detailed collection methods.

In general, registry information is useful for understanding a study’s planned question and recorded design. When outcome estimates and analysis details are absent, the registry cannot replace a results report that presents group data, comparisons, uncertainty, and analytic methods. The evidence available in this record is consequently descriptive of study registration and selected outcome fields, rather than sufficient to judge comparative performance.

13. Why This Trial Matters Statistically

This study raises several statistical issues that are important in clinical comparisons. First, its stated broad hypothesis concerns no difference in clinical performance, while the named primary endpoint is a particular assessment of lens surface wettability. A broad claim and a specific measured endpoint are not interchangeable. Interpretation requires knowing which outcome and time point anchor the conclusion, and whether a clinically meaningful difference was defined.

Second, the primary endpoint is assessed at 15min and 6hrs, and the registry lists 19 outcome measures. In general, multiple outcomes and times make prespecification and multiplicity planning important. They affect how evidence from individual comparisons should be interpreted. The record does not report the analysis plan or multiplicity approach, so readers cannot determine how the study intended to distinguish primary evidence from other findings.

Third, design descriptions need to align with the analysis. The registry classifies the study as parallel, while the arm descriptions refer to matched pairs at each visit. This does not by itself establish a design error, but it leaves the structure of observations and the method for accounting for them unclear. A complete analysis report would explain how assignment, visits, and potentially related measurements were handled.

Finally, statistical interpretation depends on estimates and their uncertainty, not solely on a stated hypothesis or a study completion status. No primary comparison or analysis is reported in the registry record. This makes the entry useful for identifying the intended question, but not for judging the precision or evidential strength of a comparative result.

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 interpreting this specific study is that the registry record does not report numerical primary-endpoint results or statistical analyses. Without group summaries, a comparison estimate, or an uncertainty interval, the direction, size, and precision of the wettability findings are unknown. The endpoint is defined at two times, but no values are reported for either one.

The study description leaves important design details unresolved. The registry labels the study parallel, while the arm descriptions say subjects would receive either the test or control lens as a matched pair at each visit. It does not explain the relationship between these statements, the order or timing of visits, or how measurements from the same participant were handled. The identity of the masked role and the allocation procedures are also not reported.

The record names 19 outcome measures but does not provide a statistical analysis plan, multiplicity strategy, analysis population, or missing-data approach. It does not report endpoint-specific denominators, participant flow, or the number of usable measurements at each time point. These omissions prevent assessment of whether the reported enrollment corresponds to the data that would be used for the primary comparison.

The primary endpoint’s scale is described, but the record does not explain the assessment procedure, intermediate scoring rules, or assessor reliability. It also does not report a threshold for a clinically important difference or an equivalence margin. Finally, adverse-event counts lack a stated observation period and deaths are not reported in the registry record. These limitations concern what can be interpreted from the registry entry; they do not establish how the study was conducted beyond the details recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses — NCT02185105.
• Registry record last updated 2017-03-07; status last verified 2017-01.
• Results first posted 2017-01-02.
• 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 describes a completed study of Biofinity Toric MTO lenses, comparing comfilcon A MTO with comfilcon A. It lists randomized allocation, single masking, a parallel design, enrollment of 30, and myopia and astigmatism as conditions. The recorded start and primary completion are both 2014-06, and CooperVision, Inc. is the sponsor.

The primary endpoint is an objective investigator assessment of lens surface wettability at 15min and 6hrs, using a 0-to-4 scale. The record states that 19 outcome measures are listed and zero analyses are reported. It does not report numerical wettability results or statistical comparisons. The adverse-event entries record zero serious and zero other adverse events among 30 at risk in each group; deaths are not reported in the registry record.

Accordingly, the entry describes the study question and selected design and safety fields, but does not provide enough outcome or analysis information to determine comparative performance or estimate the precision of a lens-to-lens difference.