Evaluation of On-eye Optical Performances of the RMY-100 Lens: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of On-eye Optical Performances of the RMY-100 Lens (NCT03670277), a non-randomized na study. The primary outcome is Distance Spherical Aberration (Z4, 0).

2. Clinical Question

The question concerns an optical measurement rather than a direct measure of a participant’s experience or a clinical outcome. The record also lists distance off-axis refraction at ±10°, ±20°, and ±30° retinal eccentricities, and near off-axis refraction at ±30° retinal eccentricities, as secondary outcomes. These measures extend the assessment beyond the primary distance spherical-aberration endpoint, but their results are not reported in the registry record.

The comparison requires cautious interpretation. Participants were not randomly allocated, and the two groups entered the study with different lens histories: the Test arm received the study soft contact lens, whereas Control participants were established orthokeratology wearers. The registered measurement conditions also differ between groups. Consequently, the clinical question is descriptive and comparative, but the design does not by itself isolate the effect of lens type from differences between groups or measurement conditions.

3. Trial Design

NCT03670277 is a completed, non-randomized, parallel, non-masked study of the RMY-100 lens. The registry lists enrollment as 28 and identifies Visual Acuity as the condition. The sponsor is Johnson & Johnson Vision Care, Inc. The recorded study period began on 2018-08-22, with primary completion on 2019-02-19. The phase is listed as NA.

The study description calls it a bilateral, non-dispensing study with a Test arm and a concurrent Control arm. Test participants were bilaterally fitted with the study soft contact lens, etafilcon A, but the endpoint was measured in the right eye only. Control participants were established orthokeratology lens wearers; the investigator judged which eye had the better orthokeratology fit, and that eye was measured. Allocation was non-randomized and masking was absent.

For the primary endpoint, the Test group had baseline measurements and a post-lens-fitting measurement after fitting at Visit 2. The Control group had one study visit recording baseline measurements on the bare eye, without a sponsor-implemented intervention. Thus, the record describes different measurement conditions and time points across the arms. The Control measurement is not described as a post-fitting measurement under a newly assigned treatment.

The primary endpoint timeframe is “Up to Post Lens Fitting Evaluation.” The record describes four outcome measures and six analyses, but does not report the specific analysis details or numerical primary results. Its non-randomized allocation means the arms should not be treated as a like-for-like controlled comparison. The registry record does not report a randomization procedure, masking procedure, or a detailed statistical analysis plan.

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

Analysis population for the primary outcome, as defined in the registry: All subjects who were administered any test article excluding subjects who dropped out prior to administering any test article. At least one observation was recorded.

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: All subjects dispensed a study lens

6. Primary Endpoint

The registry lists the primary outcome as Distance Spherical Aberration (Z4, 0), measured over Up to Post Lens Fitting Evaluation.

The primary endpoint is distance spherical aberration (Z4, 0), expressed in microns. It is a continuous optical measurement for a 5-mm pupil. The record states that an aberrometer, COAS by AMO, measured spherical aberration with a distant viewing target at 4 m. Measurements were taken at baseline and after test-lens fitting for the Test group. The Control group’s baseline measure was taken on the bare eye.

In general, an optical aberration measure characterizes how an eye’s optical system departs from an idealized focusing condition. Spherical aberration describes an optical property across the pupil; measuring it can therefore contribute to an assessment of on-eye optical performance. It is not itself a direct report of visual experience, and its interpretation should not be substituted for a clinical outcome that was not measured or reported.

The endpoint is specified as a mean, with standard deviation as the dispersion measure. A mean describes the central value of a group’s measurements, while a standard deviation describes the spread of individual measurements around that mean. Both are useful for understanding a continuous outcome, but neither conveys the uncertainty of a comparison by itself. Confidence intervals and the analysis model would add information about precision and inference; those endpoint results and methods are not reported in the registry record.

Because the Test and Control measurements differ in timing and eye-selection rules, a difference in observed means, if reported, would need interpretation in light of those design features. The primary endpoint value and a numerical between-arm estimate are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered primary endpoint is a continuous measurement summarized as a mean and standard deviation. A mean is the arithmetic center of observed values. Standard deviation describes how dispersed those values are around the mean. In general, these summaries help readers distinguish the typical measurement from variability among observations. They do not, on their own, show how precisely a group mean or between-group contrast has been estimated.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity, such as a mean or a difference between group means. A narrower interval indicates greater precision under the assumptions of the analysis; a wider interval indicates less precision. It is not a guarantee that the true value lies within a particular interval, and it does not resolve bias caused by a non-randomized design or unequal measurement conditions. The registry record does not report a confidence interval for the primary endpoint.

How does the design affect a comparison?

The study is parallel but non-randomized and non-masked. Parallel means participants were assigned to one of the study arms rather than crossing through both arms as described in a crossover design. Non-randomized allocation means that assignment was not described as being determined by chance. In general, this leaves open the possibility that groups differ in characteristics related to the outcome. Non-masking can also matter when judgments or measurement procedures could be influenced by knowledge of group assignment. The record does not report additional methods to reduce these risks.

The eye-selection rules also matter. The Test arm’s endpoint was measured in the right eye, while the Control arm used the eye judged by the investigator to have the better orthokeratology fit. These rules do not select eyes in the same way. In addition, the Control group’s primary measurement was on a bare eye at baseline, whereas the Test group had a post-fitting measure with the study lens on eye. An unadjusted difference between such measurements, if available, could combine differences in lens condition, participant characteristics, eye selection, and timing. The registry record does not report a model that separates these influences.

Why can over-dispersion matter?

In general, over-dispersion refers to variability greater than a statistical model expects. It is especially relevant for count outcomes when a model assumes more consistency than the data exhibit. The primary endpoint is continuous, so count-model over-dispersion is not the central issue for its stated summary. For continuous measurements, variation and distributional assumptions still matter: unusually heterogeneous observations or departures from model assumptions can affect standard errors and confidence intervals. The registry record does not report diagnostics or a distributional assessment for the primary endpoint.

What does the planning assumption mean?

The planning illustration is described as based on the observed effect, using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It considers detecting a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial used those design choices. The record explicitly describes the illustration as separate from the trial’s own design. The primary effect estimate needed to interpret a planning illustration is not reported in the registry record.

In general, a sample-size calculation asks how much information a future study might need to detect a specified effect under stated assumptions. It is not a measure of the probability that a completed study’s finding is true. Nor is a post hoc calculation based on an observed effect a substitute for a prespecified design calculation. Any sample-size figures should be understood as planning illustrations, not observed power. The record does not report the trial’s own sample-size justification.

How should significance testing be read?

In general, a significance test evaluates how compatible observed data are with a specified null hypothesis under a model. A p-value is not the probability that the null hypothesis is true, and it does not measure clinical importance. Interpretation also depends on the estimate and its precision, assumptions, outcome selection, and the study design. The registry record does not report a primary endpoint p-value or the test used.

The stated two-sided significance level in the planning assumptions is not evidence that the same threshold was used for the trial’s analysis. The analysis plan, including any prespecified hypothesis, model, covariate adjustment, handling of repeated measurements, and treatment of multiplicity, is not reported in the registry record. Without those details and the numerical endpoint results, inferential conclusions cannot be reconstructed.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Test", "Control")
n   <- c(17, 7)
m   <- c(0.35, 0.364)
sp  <- c(0.066, 0.212)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Test  17  0.350  0.066  0.316  0.384
CARM  Control  7  0.364  0.212  0.168  0.560

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists four outcome measures and six analyses. It identifies the primary endpoint as distance spherical aberration and lists secondary outcomes concerning distance and near off-axis refraction. However, it does not describe which analysis corresponds to each outcome, how many contrasts were planned, or whether the analyses were prespecified in a statistical plan.

In general, testing multiple outcomes or contrasts can increase the chance that at least one result appears statistically notable by chance. Methods such as an adjustment to significance thresholds or a hierarchical testing strategy can address multiplicity, but no such procedure is reported in the registry record. The record also does not report whether the primary endpoint was protected from other analyses by a prespecified testing sequence.

Missing-data handling is not reported in the registry record. The primary endpoint population is described as subjects administered any test article, excluding subjects who dropped out before administering any test article, with at least one observation recorded. This defines a population condition but does not explain how missing baseline or follow-up measurements were handled, whether participants with incomplete observations were included in each analysis, or whether imputation was used.

The record does not report the number of missing measurements, reasons for missingness, or an assessment of whether missingness differed by arm. It also does not describe an intention-to-treat analysis population or another analysis population beyond the stated endpoint population. Those omissions limit assessment of selection and missing-data bias. The exact model, covariates, repeated-measures handling, and sensitivity analyses are not reported in the registry record.

12. 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 record reports no serious adverse events in the Test group, with 20 at risk, and no serious adverse events in the Control group, with 8 at risk. It also reports no other adverse events in either group: the reported at-risk counts are 20 for Test and 8 for Control. Deaths are reported as 0 in each group.

These figures describe events recorded in the registry, not proof that no events occurred outside the record or that there is no safety risk. An observed count of zero can occur when an event is uncommon, when observation is limited, or when event ascertainment is incomplete. The registry record does not report further detail on safety monitoring, exposure duration, event definitions, or the timing of event collection.

The at-risk counts are the denominators listed for these safety summaries. They should not be replaced by the enrollment figure, and they do not establish that the safety groups and the primary endpoint analysis population were defined identically. No serious adverse event terms are listed. These descriptive counts do not support a causal safety comparison, particularly given the non-randomized design and differences between the arms.

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

The record establishes that the study evaluated on-eye optical performance of the RMY-100 lens and included a non-randomized orthokeratology control arm. It specifies distance spherical aberration as the primary endpoint and describes how the optical measurement was collected. It also records secondary off-axis refraction outcomes and safety counts.

It does not report the numerical primary endpoint result. Therefore, the registry information does not show the observed spherical-aberration mean, variability, between-arm estimate, or uncertainty. It cannot establish whether any difference was small or large, precise or imprecise, or statistically distinguishable. The numerical findings for the listed secondary outcomes are also not reported in the registry record.

Even if a numerical contrast were available, its interpretation would be limited by non-randomized allocation, lack of masking, different eye-selection procedures, and different measurement conditions. Test participants were measured with the study lens after fitting, while the Control group’s endpoint was measured on the bare eye at baseline. These aspects make a direct causal interpretation difficult. The registry record does not report statistical adjustments that would resolve the resulting concerns.

The endpoint is an optical quantity. It should not be treated as a complete measure of visual function, participant experience, or overall clinical outcome. The record’s condition listing and outcome descriptions do not provide results for visual acuity or establish that a change in spherical aberration corresponds to a meaningful clinical difference.

In general, an estimate describes the observed data, while its uncertainty and design determine how strongly it can support broader inference. Here, the primary estimate and its uncertainty are not reported in the registry record. The appropriate reading is consequently limited to the study’s design, measurement definitions, and recorded safety counts, rather than a claim that either lens approach produced a particular effect.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of why an endpoint definition alone is not enough to interpret a comparison. It identifies a continuous optical measurement, the instrument and viewing conditions, the eye-selection rules, and the timing of measurement. Those details help clarify what the endpoint represents and what groups were actually measured.

At the same time, the design features illustrate how non-randomized comparisons can be difficult to interpret. Established orthokeratology wearers were compared with participants fitted with a study soft contact lens. The groups were not assigned by chance, and the endpoint measurements differed in eye selection and lens condition. These choices matter because a statistical contrast cannot remove design differences simply by being calculated.

The study also highlights a distinction between an optical surrogate-like measure and outcomes that directly describe visual function or experience. Spherical aberration can characterize an aspect of ocular optics, but the registry record does not report the primary result or establish its relationship to a clinical benefit. Careful interpretation keeps the measured quantity separate from broader conclusions.

Finally, the record underscores the value of transparent reporting of results and methods. Numerical estimates, confidence intervals, analysis populations, missing-data procedures, and multiplicity methods would allow readers to judge precision and robustness. Their absence from the registry record means that the design can be described, but the primary statistical finding cannot be independently interpreted from this record.

15. 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 trial affect interpretation. The allocation was non-randomized, so group membership may be associated with participant characteristics or treatment history. The Control participants were established orthokeratology lens wearers, whereas the Test participants received the study soft contact lens. The registry record does not report adjustment methods to account for differences between these groups.

The primary measurement conditions were not parallel across arms. Test participants were measured at baseline and after fitting, with the post-fitting measure taken with the test lens on eye. Control participants had one visit recording baseline measurements on the bare eye and no sponsor-implemented intervention. Consequently, the record does not describe a matched post-treatment comparison under the same conditions.

Eye selection also differed: the Test arm used the right eye, while the Control arm used the eye judged by the investigator to have the better orthokeratology fit. This creates potential differences in how the measured eye was selected. The study was non-masked, and the registry record does not report whether measurement or analysis procedures were otherwise protected from knowledge of arm assignment.

The numerical primary and secondary outcome results, confidence intervals, and analysis methods are not reported in the registry record. Nor are missing-data procedures, multiplicity handling, sensitivity analyses, or a sample-size justification for the trial’s own design. Safety figures are descriptive and do not provide event timing or detailed ascertainment information. These limitations prevent a full assessment of effect magnitude, precision, robustness, and causal interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of On-eye Optical Performances of the RMY-100 Lens — NCT03670277.
• Registry record last updated 2025-04-25; status last verified 2025-04.
• Results first posted 2022-01-14.
• 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.

19. Record Summary

NCT03670277 is a completed, non-randomized, non-masked parallel study evaluating the on-eye optical performance of the RMY-100 lens. The registry lists enrollment as 28 and identifies etafilcon A as the Test intervention and habitual orthokeratology lenses as the Control intervention.

The primary endpoint is distance spherical aberration (Z4, 0), measured in microns for a 5-mm pupil. Test-arm measurements included baseline and post-fitting assessment with the study lens on eye. Control measurements were taken at baseline on the bare eye, using the eye judged to have the better orthokeratology fit.

The record lists secondary off-axis refraction outcomes and reports zero serious adverse events, zero other adverse events, and zero deaths in each arm. The numerical primary and secondary endpoint results, uncertainty estimates, and detailed statistical methods are not reported in the registry record. The design and measurement differences limit causal interpretation of any arm contrast.