Performance and Safety of Otinova® Ear Spray: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Performance and Safety of Otinova® Ear Spray (NCT05370209), a na na study. The primary outcome is Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea.

2. Clinical Question

3. Trial Design

This was a prospective, post-market clinical follow-up investigation of Otinova® Ear Spray in the treatment of external otitis symptoms. The registry record lists otitis externa as the condition, identifies Circius Pharma AB as sponsor, and describes the intervention as a device. The registered model is single-group, with no comparator arm; allocation is listed as NA and masking as none. Phase is listed as NA.

The intervention regimen was 1-2 sprays twice daily for 7 days. Enrollment was 28. The registry lists a start date of 2022-05-01 and a primary completion date of 2023-11-27, while the study status is terminated. The reason for termination is not reported in the registry record. These dates and status describe the registered study, but do not establish whether all planned follow-up or analyses were completed.

The primary outcome was clinical cure of swelling, erythema and otorrhea at Day 7. Listed secondary outcomes include changes in itching, otalgia and tenderness; microbes, moisture and volume in the ear canal; user handling; sleep; pain-relief medication use; and antibiotic use. The record lists nine outcome measures but reports no outcome analyses. As a single-group study, it can describe outcomes among participants with available data, but it cannot directly estimate a comparative treatment effect against a control group. Further details of the protocol, recruitment, follow-up completion and analysis populations are 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 Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea, measured over Day 7.

The primary endpoint is a binary definition of clinical cure at Day 7. A participant counts as cured only when each of the listed clinical signs—swelling, erythema and otorrhea—is scored as 0. Each sign is assessed on a scale from 0-2, where 0 means none, 1 means mild/moderate and 2 means severe. The endpoint is therefore based on a joint criterion: a participant with any listed sign scored above 0 would not meet the stated cure definition.

As a general statistical consideration, an endpoint that requires all specified signs to be absent is easy to express as a participant count or proportion and gives a clear, clinically interpretable threshold. It also differs from an endpoint based on average symptom change: partial improvement in some signs does not by itself satisfy the stated cure criterion. This can make the endpoint stringent, and its result depends on the scoring and completeness of assessments for every listed sign.

The registry record specifies the endpoint and its Day 7 timeframe, but does not report the number meeting the cure definition, the denominator used for that analysis, or an estimate of uncertainty. It is therefore possible to explain what the endpoint measures, but not to determine the observed cure proportion or its precision from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The main statistical distinction in this investigation is between defining an endpoint and reporting an analysis of that endpoint. The record defines clinical cure as a binary outcome at Day 7: a participant either satisfies the full criterion or does not. It does not report the resulting participant count, denominator, estimate or uncertainty. The statistical methods below explain how such information would ordinarily be interpreted; they do not imply that any particular analysis was performed for this study.

What does a binary endpoint represent?

A binary endpoint assigns each participant to one of two outcome categories under a prespecified rule. Here, the rule requires swelling, erythema and otorrhea each to have a score of 0. The outcome is not a continuous average of symptom scores, and it is not a count of the number of signs that improved. Every required component matters to whether a participant meets the cure definition.

For a binary endpoint, a participant count is informative only alongside its denominator. The count says how many participants met the definition; the denominator says how many were included in the calculation. If the denominator differs from enrollment because some assessments are unavailable or participants are excluded, the reported proportion describes that analyzed group rather than necessarily everyone enrolled. The registry record does not report the denominator or missing-assessment handling for the primary endpoint.

How should uncertainty be considered?

An estimate based on a limited set of observations is subject to sampling uncertainty. A confidence interval is a way to express the precision of an estimate: a wider interval indicates greater uncertainty, while a narrower interval indicates more precision under the assumptions of the method. It does not remove design limitations, such as the absence of a comparator, and it does not account automatically for missing data or measurement problems. No confidence interval for the primary endpoint is reported in the registry record.

Statistical significance and clinical interpretation are also different questions. A significance test evaluates data against a specified statistical hypothesis, while clinical interpretation asks what the estimated outcome means in context. Neither can be assessed for the primary endpoint without a reported estimate and analysis. The record does not report a statistical analysis plan, a hypothesis test, or a prespecified decision threshold.

What does the single-group design allow?

A single-group study can describe the outcomes and safety events recorded among participants who receive the intervention. It does not provide a concurrent control group for estimating what would have happened under another treatment or without the intervention. Changes over time may have several explanations, so an observed before-and-after pattern, even if it were reported, would not by itself identify a causal treatment effect. In this record, the primary result is not reported, so even a descriptive endpoint estimate is unavailable.

How should planning calculations be read?

Sample-size illustrations are planning tools. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as fractions of an observed effect. Those assumptions describe a hypothetical two-arm planning exercise, not the registered single-group design. Any resulting sample sizes are planning illustrations; they are not observed power, evidence of the study’s actual design rationale, or a substitute for reported endpoint results. The sample-size justification for this investigation is not reported in the registry record.

Why can over-dispersion matter?

In general, over-dispersion means that outcome variability is greater than a statistical model assumes. If a model understates variability, its standard errors and uncertainty intervals can be too small, making results appear more precise than they are. This issue is particularly relevant to some count-data models, but the primary endpoint is specified as a participant-level binary outcome, and no fitted model or over-dispersion assessment is reported. It would be inappropriate to infer that a particular model or adjustment was used.

In short, the endpoint definition is available, but the information needed to evaluate its observed frequency and precision is not. Statistical interpretation should remain limited to the registered design and the specific outcome and safety information that the record reports.

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("Otinova® Ear Spray")
n      <- c(28)
events <- c(28)
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  Otinova® Ear Spray  28  28  100.0  87.7  100.0  87.9  100.0  88.1  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists nine outcome measures, including the primary Day 7 clinical-cure endpoint and secondary measures related to symptoms, ear-canal findings, handling, sleep, pain-relief medication use and antibiotic use. It reports no outcome analyses. The results of the primary endpoint and secondary outcomes are therefore not available for interpretation from the registry record.

When a study assesses multiple outcomes, the chance of obtaining a seemingly notable result somewhere among them can increase if results are tested repeatedly without a prespecified approach. Statistical methods may address this issue by defining a primary outcome, controlling error across tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy, whether secondary outcomes were exploratory, or how conclusions would be prioritized across outcomes. No assumptions about those choices can be made.

Missing-data handling is also not reported in the registry record. It does not state how participants without a Day 7 assessment, incomplete sign scores, withdrawals or other unavailable measurements were handled. The endpoint population is not described, and the record does not specify whether analyses were based on all enrolled participants, participants who completed treatment, or another group. These details matter because the analyzed denominator and the treatment of missing observations can affect the meaning of an estimated cure proportion.

Interim analyses and stopping rules are not reported in the registry record. The terminated status does not establish whether any interim review occurred, why the study stopped, or whether the number of participants with outcome data differs from enrollment. Without results, an analysis plan and missing-data details, no adjustment for multiplicity or assessment of analysis-population sensitivity can be verified.

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 registry reports safety counts for the Otinova® Ear Spray group. Serious adverse events affected 0 participants among 28 at risk. Other adverse events affected 4 participants among 28 at risk. Deaths are reported as 0. The registry record lists no serious adverse-event terms.

These are descriptive participant counts, not estimates of comparative risk. Because the study has a single group and no control condition, the counts cannot show whether events occurred more or less often than they would have under another treatment or without the intervention. The figures also do not, by themselves, establish whether an event was caused by the device. No causal attribution should be inferred from these counts.

A count of 0 serious adverse events in this group means none were recorded in the registry’s reported safety data; it does not establish that the possibility of such events is absent. The record does not report the event details for the other adverse events in the registry record, or provide further information about duration, severity, relatedness or timing. The safety counts should therefore be read as the limited descriptive information reported in the registry record, not as a comprehensive comparative safety assessment.

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

The registry record establishes that a prospective, single-group post-market follow-up investigation of Otinova® Ear Spray was registered for external otitis symptoms. It specifies a regimen of 1-2 sprays twice daily for 7 days and defines a primary clinical-cure outcome at Day 7. It also reports enrollment and descriptive safety counts. Those details describe the study and its recorded outcomes, but they do not answer whether the primary cure criterion was met by participants.

The primary endpoint result is not reported, and the registry lists no outcome analyses. Consequently, the posted record does not show the observed clinical-cure count or proportion, the extent of change in the listed secondary outcomes, or the precision of any effect estimate. It cannot establish benefit, lack of benefit, or equivalence to another approach. The absence of reported results should not be interpreted as a result of no change.

The design also limits what could be concluded even if descriptive outcome data were available. With no comparator group, outcomes in the intervention group cannot be directly contrasted with outcomes under another condition. A change from an initial assessment to Day 7, if reported, could not by itself identify the effect attributable to the spray.

The reported safety counts indicate no serious adverse events and four participants with other adverse events among 28 at risk, with deaths reported as 0. These counts do not establish comparative safety or causation. The terminated status is recorded, but its reason and implications for outcome collection are not reported. The most defensible interpretation is therefore narrow: the registry supplies a study description, endpoint definition and limited safety counts, while the outcome evidence needed to assess performance is not reported in the registry record.

14. Why This Trial Matters Statistically

This investigation illustrates why a clear endpoint definition is not the same as an interpretable result. The primary outcome is described precisely: clinical cure at Day 7 requires every specified sign—swelling, erythema and otorrhea—to be scored as 0. Yet without the number meeting that definition, the analyzed denominator and an estimate of uncertainty, readers cannot assess how often the endpoint occurred or how precisely it was estimated.

It also demonstrates the distinction between descriptive evidence and comparative evidence. A single-group post-market follow-up can collect information about outcomes and adverse events in people using the device. Without a comparator, however, it cannot directly distinguish changes associated with the intervention from changes that might occur for other reasons. That limitation should shape interpretation before any result is considered.

The registry status and reporting completeness matter as well. The study is listed as terminated, and the record lists nine outcome measures but no analyses. The reason for termination, analysis populations, missing-data approach and multiplicity strategy are not reported. These omissions prevent assessment of how closely the reported record reflects planned outcome collection and analysis.

Finally, the stated sample-size assumptions concern a hypothetical two-arm planning exercise, whereas the registered study is single-group. Planning illustrations should not be mistaken for observed power, an actual design justification, or evidence about the clinical endpoint. The case underscores the statistical value of complete outcome reporting: design, endpoint, denominator, uncertainty, missingness and analysis choices all contribute to what a study can support.

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.

The principal limitation for interpreting performance is that the registry record does not report the primary endpoint result or any outcome analyses. Although the cure definition and Day 7 timeframe are specified, the number meeting the definition, analyzed denominator and estimate of precision are unavailable. The listed secondary outcomes likewise have no reported analyses.

The single-group design has no concurrent comparator. Any descriptive outcomes would therefore lack a direct basis for comparison with another treatment or control condition. Allocation is listed as NA and masking as none, and no like-for-like control comparison is registered. The record does not report details that would allow assessment of how these design features affected measurement or reporting.

The study status is terminated, but the reason for termination is not reported in the registry record. It is also not stated whether termination affected recruitment, follow-up, endpoint completion or analysis. Enrollment is recorded as 28, but the number contributing to the primary endpoint is not reported. Missing-data procedures and analysis-population definitions are likewise absent.

Other limitations include the lack of a reported statistical analysis plan, multiplicity strategy, sample-size justification for the actual single-group study, interim-analysis information, and outcome estimates with uncertainty. The endpoint is assessed at Day 7; longer-term outcome results are not reported in the registry record. The safety information is limited to participant counts and does not provide event-level details in the registry record for this analysis. These gaps restrict interpretation without indicating what unreported analyses or events might have shown.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Performance and Safety of Otinova® Ear Spray — NCT05370209.
• Registry record last updated 2024-11-15; status last verified 2024-09.
• Results first posted 2024-11-15.
• 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 NCT05370209 as a prospective, post-market, single-group clinical follow-up investigation of Otinova® Ear Spray for external otitis symptoms. The listed regimen was 1-2 sprays twice daily for 7 days. Enrollment was 28; the study status is terminated. Allocation is listed as NA and masking as none.

The primary outcome is clinical cure at Day 7, defined by swelling, erythema and otorrhea each being scored as 0 on a scale from 0-2. Nine outcome measures are listed, but the registry reports no outcome analyses. The primary result and the reason for termination are not reported in the registry record.

For safety, the record reports 0 serious adverse events among 28 at risk, other adverse events affecting 4 among 28 at risk, and deaths of 0. These are descriptive counts from the single intervention group, not comparative estimates.