A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications (NCT03506568), a randomized na study. The primary outcome is Compliance Percentage.

2. Clinical Question

3. Trial Design

The record describes a completed, randomized, prospective clinical trial with a parallel-group model and single masking. It lists the study as phase NA. The record does not identify who was masked, describe the randomization procedure, or report how allocation was concealed.

Enrollment was 50. The record lists a control group with no reminder and an intervention group using the D3 app’s integrated daily reminders. The stated control condition left instructions and smartphone use unchanged. In the intervention condition, the app was turned on to deliver a smartphone push notification and audio and visual reminders from the device. The record does not state the allocation ratio or give enough detail to reconstruct participant flow through the groups.

The trial start date is 2020-10-02, and the primary completion date is 2021-06-04. The status is completed. The primary outcome was compliance percentage during a 50-day study cycle, defined using dose-monitor recordings within 3 hours of the prescribed time. Patient Satisfaction is listed as a secondary outcome.

Although randomized allocation supports a comparison between assigned conditions in principle, the registry record does not report a full statistical analysis, participant-level data, or a formal estimate of the between-group effect. The outcome entries list n as 1.0 for the control group and 2.0 for the reminder group, while enrollment is reported as 50. The record does not explain how these outcome n entries relate to enrollment or how the outcome summaries were produced. That gap limits interpretation of the displayed arm summaries.

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.

Stage 1

Stage 2

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 Compliance Percentage, measured over 50 days.

The primary endpoint is Compliance Percentage. It represents the percentage of days on which the dose monitor recorded dosing within 3 hours of the prescribed time, divided by the number of days in the study cycle. The registered timeframe is 50 days. The endpoint therefore reflects monitor-recorded dosing behavior according to a timing rule, rather than a direct measure of medication ingestion or a clinical measure of glaucoma status.

An adherence endpoint is relevant to this study because the intervention is intended to influence eye-drop-taking behavior, while the monitor records cap-removal activity. General statistical context: a device-based measure can provide a consistent operational definition of the behavior being studied, but the recorded behavior should not automatically be treated as proof that medication was instilled or that a clinical outcome changed. The registry record defines the measure using monitor records and does not report validation results for this trial.

The endpoint is reported as a mean, with standard deviation as the stated measure of spread. The intervention summary includes a standard deviation; the control summary does not. The record does not give a confidence interval or a formal comparison estimate. As a result, the reported means describe the posted summaries, but their precision and the uncertainty around the difference between study conditions cannot be fully assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are only partly described in the registry record. It identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. It also identifies a randomized, single-masked, parallel design. The record does not report the statistical plan, the specific primary comparison method, a confidence interval, a p-value, or a formal analysis result. It lists zero analyses. The following explanations describe general statistical concepts; they should not be read as claims that these methods were used in this trial.

What does a mean describe?

General: a mean is a measure of the central value of a set of observations. For this endpoint, the mean compliance percentage summarizes the recorded adherence values for the observations contributing to an arm’s result. It does not show the range of values, the shape of their distribution, or whether a small number of observations strongly influenced the average. The posted summaries do not include participant-level observations, so those features cannot be assessed from the registry record.

What does a standard deviation describe?

General: a standard deviation describes how dispersed observations are around their mean. It is not a confidence interval and does not directly quantify uncertainty in the mean. The registry record reports a standard deviation for the reminder arm and for Baseline Adherence, but not for the control arm. Without the control spread, readers cannot compare the reported within-group variability across the two randomized conditions using the posted summaries.

Why is a confidence interval useful?

General: a confidence interval gives a range of values compatible with the data under a specified statistical method and its assumptions. For a between-group comparison, an interval around the effect estimate helps show both the estimated direction and the precision of that estimate. A narrow interval indicates greater precision than a wide interval, though interpretation also depends on the chosen measure and analysis. No confidence interval for the primary comparison is reported in the registry record. No new interval can be reconstructed from the posted summaries because the control spread and a clear account of contributing observations are absent.

What can a significance test add?

General: a significance test evaluates how compatible the observed data are with a specified null hypothesis under the test’s assumptions. A p-value does not measure the size or importance of an effect, and it does not replace an effect estimate with an uncertainty interval. The record does not report a p-value or test for the primary outcome. Therefore, there is no basis in the registry record for calling the primary comparison statistically significant or nonsignificant.

Why do group counts and missing observations matter?

General: the number of observations contributing to each summary helps determine its precision and how well it represents the randomized group. Missing observations can also affect interpretation, particularly if the chance of missing data is related to adherence or assignment. The record reports enrollment of 50, but the primary outcome entries list n as 1.0 and 2.0 for the randomized groups. It does not explain the relationship between these entries, enrollment, and the analyzed observations. It also does not describe missing monitor records, withdrawals, exclusions, or imputation. The impact of missingness therefore cannot be evaluated.

What does the planning illustration mean?

General: sample-size planning uses assumptions about an effect, variability, significance level, allocation, and analysis method to illustrate the amount of information a future study might need. A planning illustration based on an observed effect is not an observed-power calculation and does not show that the trial was adequately powered. The registry record states that its planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with effects to detect expressed as fractions of the observed effect. The record does not report the trial’s own design justification or sample-size calculation. The planning assumptions should not be mistaken for the trial’s original statistical plan.

What remains unknown about the analysis?

The registry record does not report whether the primary analysis followed randomized assignment, whether any adjustment variables were used, how repeated or incomplete monitor records were handled, or whether an interim analysis occurred. It does not describe distributional checks or the method used to calculate the reported standard deviations. General: these details matter because an analysis method should match the outcome structure and study design, and transparent reporting lets readers assess the consequences of assumptions. In their absence, the posted means are best interpreted descriptively rather than as a fully documented estimate from a specified inferential model.

10. Multiplicity, Missing Data and Analysis Populations

Patient Satisfaction is listed as a secondary outcome, and the record reports one secondary outcome posted. The primary outcome is compliance percentage. The registry record does not report a multiplicity strategy, such as whether tests across outcomes were adjusted or which outcome comparisons were designated as confirmatory. It also does not report results for Patient Satisfaction in the registry record for this analysis. Without the analysis plan and outcome-level inferential results, the possibility and handling of multiple comparisons cannot be assessed.

Missing-data methods are not reported in the registry record. The primary endpoint depends on dose-monitor records during the 50-day cycle, but the record does not state how days without a recording were classified, whether device nonuse was distinguished from missing or failed recording, or how incomplete follow-up was handled. It does not describe exclusions, imputation, or sensitivity analyses. These omissions matter because the endpoint’s calculation depends on recorded days and the denominator used for the study cycle.

The record gives an enrollment figure of 50, but does not identify the analysis population or explain participant flow. The reported outcome n entries are 1.0 for control and 2.0 for the reminder group; the registry record does not reconcile these with enrollment. It also does not say whether the displayed summaries include all randomized participants, only those with complete monitor data, or another subset. No intention-to-treat or per-protocol analysis is described. Without those details, it is not possible to determine how missingness, exclusions, or analysis-population choices may have influenced the posted summaries.

The registry record also does not report interim analyses or stopping rules. Their presence or absence should not be inferred from the absence of a description.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety record lists serious adverse events, other adverse events, and deaths for the control, integrated reminder, and Baseline Adherence groups. For control, 2 were listed at risk for serious adverse events and 0 were affected; 2 were listed at risk for other adverse events and 1 was affected. For the reminder group, 3 were listed at risk for serious adverse events and 0 were affected; 3 were listed at risk for other adverse events and 0 were affected. The reported deaths for each of those two groups were 0.

The separate Baseline Adherence group lists 50 at risk for serious adverse events and 0 affected, and 50 at risk for other adverse events with 1 affected. It lists 1 death. The record does not explain how this baseline group relates to the randomized safety groups or the timing and attribution of the listed death. These entries should therefore be read as registry safety counts for the named groups, not as a comparative safety analysis.

Zero serious events recorded in a group does not prove that no safety concerns occurred, especially when the number listed at risk is limited and the record provides no event descriptions or inferential comparison. The registry record reports no serious adverse-event terms. It does not give enough information to assess event timing, relatedness, severity beyond the serious-versus-other categories, or completeness of ascertainment.

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

The registry record shows that the primary outcome was defined as monitor-recorded compliance percentage, based on dosing recorded within 3 hours of the prescribed time during a 50-day cycle. It reports means of 73.9 for control and 94.6 for the integrated daily reminder condition. The reminder summary includes a standard deviation of 7.6, while the control summary has no reported spread. Baseline Adherence is reported separately as 93.99 with a standard deviation of 16.2.

These are descriptive values, not a complete statistical comparison. The record does not report a confidence interval or statistical test for the primary outcome, and it lists zero analyses. Its outcome n entries for the randomized groups are 1.0 and 2.0, with no explanation of how they relate to enrollment of 50. This uncertainty about the contributing observations, combined with missing information about the control group’s variability and missing monitor data, prevents a precise assessment of the contrast between the groups.

The record also does not establish that the measured cap-removal behavior represents medication instillation, nor does it report a clinical outcome showing a change in glaucoma status. General: a behavioral measure can be informative about the behavior it operationally records, but conclusions should remain within the scope of that measurement. Here, the registered endpoint concerns monitor-recorded dosing behavior under a specified timing rule.

The completed randomized design is relevant to evaluating the reminder strategy, but the publicly reported information is insufficient to determine the robustness of an estimated effect or its uncertainty. It does not justify a claim that the reminder improved adherence, nor a claim that it had no effect. The defensible interpretation is limited to describing the registry’s outcome summaries and identifying the information needed for a clearer comparison.

13. Why This Trial Matters Statistically

This trial is statistically notable because it connects a device-based behavioral measure with a randomized comparison of a reminder strategy. The primary endpoint is operationally defined: it uses dose-monitor records to identify days with dosing recorded within 3 hours of the prescribed time. A clearly specified outcome makes it possible to understand what the reported percentage is intended to represent, even though the registry record does not establish that recorded cap removal equates to medication instillation.

The study also illustrates why randomized design and complete results reporting are separate requirements for interpretation. Randomized allocation can support a fair comparison in principle, but readers still need clear group counts, outcome definitions, uncertainty estimates, and analysis methods. Here, the outcome n entries of 1.0 and 2.0 are not reconciled with enrollment of 50. The control spread, comparison confidence interval, and inferential test are not reported. These gaps prevent a full statistical reading of the reported means.

Baseline Adherence is reported as a separate outcome group, which calls for care in distinguishing it from the randomized control and reminder conditions. The safety record likewise includes a separate baseline group, and its relationship to the randomized groups is not explained. Distinguishing such groups is important: a baseline description is not automatically a randomized comparator or a follow-up estimate.

The registry record’s omissions are useful to identify because they define what the posted evidence can support. A reader can describe the endpoint and the reported summaries, but cannot reconstruct the primary analysis, evaluate missing-data assumptions, or quantify comparative precision from the stated information. This is a reporting and interpretation issue, not proof that particular analyses were or were not conducted outside the registry record.

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 trial-specific limitations of interpretation arise from incomplete reporting. The record provides no detailed participant characteristics or eligibility criteria, so the population represented by the enrolled group cannot be described beyond the stated glaucoma and medication-adherence context. The intervention and control conditions are described, but the randomization procedure, allocation concealment, and identity of the masked party are not reported.

The largest ambiguity in the posted primary outcome is the relationship between enrollment and the arm-level n entries. Enrollment is reported as 50, while the outcome summaries list n as 1.0 for control and 2.0 for the integrated reminder group. The registry record does not explain whether these are analyzed participant counts or what they represent. It also does not provide participant flow or a clear analysis population. This limits assessment of representativeness and precision.

The control summary has no reported standard deviation, and neither randomized group has a reported confidence interval or inferential test. The record does not state how missing dose-monitor records were handled, how the 50-day denominator was applied when records were incomplete, or whether any values were excluded. These details are important for a measure based on device recordings.

Patient Satisfaction is listed as a secondary outcome, but no results or multiplicity approach are reported in the registry record. There is no reported account of baseline adjustment, interim analyses, a statistical analysis plan, or the original sample-size justification. The planning assumptions described in the record do not substitute for the trial’s own design rationale. Safety counts are also sparse and include a separate baseline group whose relationship to the randomized groups is not explained. Together, these limitations mean the registry summaries do not permit a complete assessment of effect precision, missing-data bias, or comparative safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Universal Eye Drop Adherence Monitor to Measure and Improve Adherence to Ocular Medications — NCT03506568.
• Registry record last updated 2023-02-21; status last verified 2023-02.
• Results first posted 2023-02-21.
• 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 record describes a completed randomized, single-masked, parallel trial of the Devers Drop Device app for eye-drop adherence. The control condition had no reminder; the intervention used daily smartphone and device reminders. Enrollment was 50, and the registered primary outcome was compliance percentage based on dose-monitor records within 3 hours of the prescribed time during a 50-day cycle.

The posted primary means are 73.9 for control and 94.6 for the reminder group; the reminder group’s standard deviation is 7.6. Baseline Adherence is listed separately with a mean of 93.99 and standard deviation of 16.2. No primary comparison test or confidence interval is reported, and the outcome n entries are not reconciled with enrollment. Missing-data methods, analysis populations, and multiplicity handling are not reported in the registry record.