A Study Evaluating the Safety of the Nasal Pump: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study Evaluating the Safety of the Nasal Pump (NCT06329687), a na phase 4 study. The primary outcome is Number of Participants With Adverse Events.

2. Clinical Question

3. Trial Design

This was a Phase 4, single-center, open-label, single-group study of the Tyrvaya nasal pump with additional silicone lubricant. The registry record lists enrollment of 5 and status as terminated. The recorded start date is 2024-02-21, and the primary completion date is 2024-02-28. The reason for termination is not reported in the registry record.

Because the study is single-group and has no listed comparator, its design is descriptive for the observed participants: it records safety outcomes in the group that received the nasal pump. Allocation is listed as NA, and masking as none. The open-label description means the study was not masked, but the registry record does not describe how outcome assessment was conducted or whether any steps were taken to reduce assessment bias.

The arm description specifies the nasal pump with additional silicone lubricant. The registry record does not report the schedule or duration of use beyond the primary outcome timeframe of 7 days, nor does it give further details about the study procedures. The enrolled population's demographics and eligibility criteria are also not reported in the registry record.

The record lists 1 outcome measure and 0 analyses. Consequently, the registry entry does not include a formal analysis plan or analysis results for the primary outcome. Sample-size justification, interim analyses, and the reasons for stopping the study are not reported in the registry record. These omissions limit what can be concluded about how the study was planned and how its completion was determined.

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 Number of Participants With Adverse Events, measured over 7 days.

The primary endpoint is the number of participants with adverse events over 7 days. It is a participant count: it concerns how many participants had at least one event, rather than how many event episodes occurred. The outcome description specifies adverse events with the nasal pump and additional silicone lubricant.

In general, a safety endpoint of this kind is used to describe the occurrence of unwanted events during a defined observation period. A defined timeframe helps clarify which events are included in the outcome, but the registry record does not report detailed event definitions, collection procedures, or rules for attributing events to the intervention. The endpoint therefore describes recorded events, not necessarily their cause.

The registry record identifies this as the primary outcome but lists 0 analyses. Safety counts are listed separately, including counts for serious and other adverse events. Those counts should be read as descriptive information about the enrolled group; without a comparator, they do not estimate a difference in safety between treatments. Further endpoint-analysis details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record names a primary safety outcome and provides group-level event counts, but it lists 0 analyses. It does not report an inferential method used to analyze the primary outcome. The concepts below explain how such data are commonly interpreted in general; they are not a description of methods used in this study unless explicitly stated in the registry record.

What does a participant count represent?

In general, a participant count indicates how many people met an outcome definition. For an adverse-event outcome, the count of participants with an event is distinct from a count of event episodes: a participant may have more than one event, but a participant-based measure counts that person once if the outcome definition is met. The primary outcome is named as the number of participants with adverse events. The registry record does not supply event-level details or explain how multiple events in one participant were handled.

The group figures include participants at risk and participants affected for serious and other adverse events. These are descriptive counts. They communicate what was recorded in the enrolled group, but by themselves do not establish the frequency expected in a wider population. In general, an estimate based on a small group is subject to substantial uncertainty, even if the count is reported precisely. No uncertainty interval is listed in the registry record.

What can a single-group design estimate?

In general, a single-group study can describe outcomes in the participants observed under its study conditions. Without a separate comparator, it cannot directly estimate a between-group treatment effect. Other factors, including underlying health, concurrent care, and how events are detected, can also affect observed safety data. The registry record does not report an analysis that separates those influences from the intervention.

Allocation is listed as NA, masking as none, and the model as single-group. The record therefore does not describe random assignment or masked assessment. These design features matter when interpreting subjective or incompletely defined outcomes, since expectations and assessment procedures can influence what is reported or recorded. The registry record does not describe procedures for event collection or adjudication, so their influence cannot be assessed from the entry.

What would a confidence interval add?

As a general statistical point, a confidence interval is a range of values compatible with the data under a specified statistical model. It communicates uncertainty about an estimate; it does not make a small study more informative than its data allow. An interval for a participant event frequency would require a stated method and an estimate. Neither an interval nor a formal analysis is listed in the registry record, and no interval should be inferred from the counts alone.

In general, a significance test addresses a particular null hypothesis under specified assumptions. A p-value is not the probability that an intervention is safe, and it does not measure the size or importance of an effect. The registry record lists no analysis records or p-values. The absence of a reported test is not evidence that a test found no difference; the study has no listed comparison group in any case.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variability is greater than a statistical model expects. It can matter for count outcomes because a model that assumes less variability than the data contain may produce overly narrow uncertainty intervals or misleading tests. The posted primary endpoint is a participant count, but the registry record does not report a count model, dispersion estimate, or analysis. There is no basis for asserting that over-dispersion was assessed or was relevant to the study's analysis.

How should planning calculations be read?

In general, sample-size calculations are planning tools that depend on assumptions about the effect to detect, variability, significance level, power, and allocation. The registry record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. These assumptions describe the illustrations, not the original single-group study design.

Any such planning figures are not observed power and do not show that the study had a particular probability of detecting an effect. They are not a sample-size justification for this trial; a design justification is not reported in the registry record. The study itself is listed as single-group, whereas the planning assumptions describe equal allocation between two arms. Those calculations therefore should not be read as evidence that the enrolled study included two arms or a randomized comparison. The registry record does not provide analysis records or a reported inferential result to which a power calculation could be attached.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Nasal Pump")
n      <- c(5)
events <- c(1)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Nasal Pump  5  1  20.0  0.5  71.6  3.6  62.4  4.3  64.1

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 1 outcome measure and 0 analyses. It identifies the number of participants with adverse events as the primary outcome, but does not report an analysis plan, a hierarchy of hypotheses, or procedures for handling multiple statistical tests. Because no analyses are listed, the registry record does not establish whether any multiplicity adjustment was planned or performed. A lack of a reported adjustment should not be interpreted as evidence that one was unnecessary or that multiple testing occurred.

The registry record does not describe how missing outcome data were handled. It does not report whether all enrolled participants completed the 7-day timeframe, whether any assessments were unavailable, or how unavailable data would be treated in the analysis. The group safety figures list 5 participants at risk, but those figures alone do not specify completeness of follow-up or the handling of missing information.

Analysis populations are not reported in the registry record. In general, an analysis population defines which participants are included in a particular analysis and how deviations or incomplete observations are addressed. Without a stated population, readers cannot determine from the registry record whether the listed figures represent all enrolled participants or a defined subset, beyond the recorded group at-risk count.

The record also does not report interim analyses, stopping rules, or a statistical analysis plan. These omissions leave important analytical choices unknown. The study's terminated status is reported, but its reason is not reported in the registry record. No conclusion about the role of interim findings, missing data, or multiplicity in that status is supported by the entry.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety record lists 5 participants at risk in the Nasal Pump group. It reports 0 participants with serious adverse events, 1 participant with other adverse events, and 0 deaths. These figures are counts of participants, not counts of event episodes. The serious adverse-event terms are not listed; the event term or terms associated with the other adverse event are not reported in the registry record.

In general, a serious adverse event category and an other adverse event category distinguish events by seriousness classification, not by whether an event was caused by an intervention. The registry record does not state whether the reported other event was considered related to the nasal pump, and it does not provide event details that would permit an independent assessment. A count of 0 serious adverse events means none are recorded in the listed group figures; it does not establish the absence of risk beyond the participants and timeframe described.

The primary outcome timeframe is 7 days. The record does not describe longer-term safety follow-up, event collection methods, or missing safety assessments. The posted counts should therefore be interpreted as a limited descriptive record, not as a comparative safety estimate.

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

The result records a small set of safety observations in a single group: the registry lists 5 participants at risk, 0 with serious adverse events, 1 with other adverse events, and 0 deaths. The primary outcome is the number of participants with adverse events during 7 days. The study is listed as terminated, and 0 analyses are recorded.

These registry entries describe what the registry entry reports; they do not establish whether the nasal pump caused an event or whether an event would have occurred without the intervention. There is no listed comparator group, and the study is not a randomized comparison. As a result, the record cannot provide a direct estimate of relative safety against another intervention. No clinical advice or treatment conclusion follows from these counts alone.

In general, a safety count from a small group is most informative as a description of those observed participants. It is less precise as a basis for estimating what might be seen in other populations or over longer periods. No confidence interval, formal analysis, or analysis population is listed in the registry record. Event descriptions and attribution are also not reported, which limits interpretation of the single other adverse event.

The findings also do not explain why the study was terminated. The reason is not reported in the registry record, and the status alone should not be treated as an explanation of the safety counts. In sum, the posted information documents the group-level safety counts and the short outcome timeframe, while leaving comparative effects, causal attribution, and broader generalizability unresolved.

14. Why This Trial Matters Statistically

This study matters statistically as an example of how design determines the scope of a safety result. Its single-group structure supports a description of events recorded among participants in that group, but not a direct comparison with another treatment. Readers should distinguish a count observed in a study from an estimate of a treatment difference.

The enrollment of 5 also makes precision an important consideration. In general, small studies can record useful safety observations, but a low or zero count does not by itself establish that an event cannot occur or that a broader population would have the same experience. A measure of uncertainty would help communicate how imprecisely a frequency is estimated; none is listed in the registry record.

The distinction between serious and other adverse events is another statistical reading point. These are separately reported categories, and a participant count is not the same as the total number of events. The registry provides limited event detail, so the counts cannot convey clinical features, timing, or attribution.

Finally, the record lists 0 analyses despite naming a primary outcome. This makes it especially important not to infer a hypothesis test, adjusted estimate, or analysis population. The planning assumptions described in the registry record are illustrations and do not change the single-group design or constitute observed power. Taken together, the entry underscores the value of reading safety counts alongside design, timeframe, and analysis reporting rather than treating any single number as a complete conclusion.

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 trial-specific limitations constrain interpretation. The study is single-center, open-label, and single-group, with no comparator listed. The registry record therefore provides no randomized or controlled basis for separating intervention effects from other influences on observed safety events. The record does not describe masked outcome assessment or other procedures intended to limit assessment bias.

Enrollment was 5, and the primary outcome timeframe was 7 days. The registry record does not describe follow-up beyond that timeframe or provide an uncertainty interval for the safety counts. It also does not report the event terms for the other adverse event, detailed event characteristics, or whether events were considered related to the pump. Serious adverse-event terms are not listed.

The record lists 0 analyses and does not report a statistical analysis plan, analysis population, missing-data approach, or interim analyses. The reason for the terminated status is not reported in the registry record. Participant eligibility criteria and baseline characteristics are also not reported, limiting assessment of who the observations represent.

The intervention is described as the Tyrvaya nasal pump with additional silicone lubricant, but further procedural details are not reported in the registry record. These gaps mean the safety counts cannot be placed in fuller context or used to assess comparative effects. The limitations do not negate the descriptive counts; they define the narrow scope of what those counts can support.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study Evaluating the Safety of the Nasal Pump — NCT06329687.
• Registry record last updated 2025-05-02; status last verified 2024-03.
• Results first posted 2025-05-02.
• 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.

19. Record Summary

The registry record describes a Phase 4, single-center, open-label, single-group study evaluating the safety of the Tyrvaya nasal pump with additional silicone lubricant. Enrollment was 5. The primary outcome was the number of participants with adverse events over 7 days. The study status is terminated; the reason for termination is not reported in the registry record.

The Nasal Pump group safety figures list 0 participants with serious adverse events, 1 with other adverse events, and 0 deaths. The record lists 1 outcome measure and 0 analyses. No comparator group is listed, and the registry record does not report a formal analysis, confidence interval, event attribution, missing-data approach, or analysis population. The counts are descriptive and do not provide a controlled estimate of comparative safety.