This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for MiBo ThermoFlo Lid Temperature Evaluation (NCT03787212), a randomized na study. The primary outcome is Posterior Eyelid Temperature (Palpebral Conjunctiva).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03787212 |
| Phase | NA |
| Condition | Dry Eye |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johnson & Johnson Vision Care, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The planned population was subjects between the ages of 18 to 80 years. The primary-outcome population is described as subjects who completed all study visits and had no protocol deviation impacting a primary endpoint. The record does not report how many subjects met that definition or provide further eligibility details.
Intervention
MiBo ThermoFlo, a device, was one of the two treatments evaluated. Subjects were described as randomly assigned to one of two treatment sequences in a contralateral fashion. The record does not describe the treatment procedure beyond the device name and post-treatment temperature assessment.
Comparator
Bruder Mask, also a device, was the other treatment. The listed sequences were MiBo ThermoFlo followed by Bruder Mask, or Bruder Mask followed by MiBo ThermoFlo. The contralateral description indicates that the comparison involved treatment across the eyes; details of sequence implementation are not reported in the registry record.
Primary question
The stated primary outcome was mean posterior eyelid temperature at the palpebral conjunctiva, assessed 12-minutes post treatment. The clinical question is whether the recorded inner-eyelid temperature differs under the two device conditions. The registry record does not report arm-level temperatures, a treatment contrast, or a statistical test, so it does not provide a numerical answer to that question.
3. Trial Design
The record describes a prospective, contralateral, single-site, single-visit, unmasked evaluation of external and internal eyelid temperature after treatment with MiBo ThermoFlo. It lists randomized allocation and two treatment sequences: MiBo ThermoFlo followed by Bruder Mask, and Bruder Mask followed by MiBo ThermoFlo. The arm descriptions state that subjects between the ages of 18 to 80 years would be randomly assigned to one of those sequences in a contralateral fashion.
The registry also classifies the model as parallel. That classification appears alongside the contralateral sequence description, rather than replacing it. The record does not explain how the parallel-model label relates to the within-participant, contralateral description, or give further details about sequence assignment, treatment periods, or any interval between treatments. Masking is listed as none.
Enrollment is recorded as 4. The study began on 2018-12-06, had a primary completion date of 2019-01-28, and is listed as terminated. The reason for termination, the number completing the visit, and whether the planned enrollment was reached are not reported in the registry record. The phase is recorded as NA.
The stated outcome time is 12-minutes post treatment. No additional visit schedule, measurement schedule, or procedures for handling sequence or eye effects are described. In a contralateral comparison, measurements from the two eyes of one participant are related rather than independent; that design feature matters for analysis. The record does not report whether any analysis accounted for that relationship. It also contains no posted analyses, so the exact analysis population and the treatment comparison actually performed cannot be established from the 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.
Period 1
| Stage | Test/Control | Control/Test |
|---|---|---|
| STARTED | 2 | 2 |
| COMPLETED | 2 | 2 |
| NOT COMPLETED | 0 | 0 |
Period 1
| Stage | Test/Control | Control/Test |
|---|---|---|
| STARTED | 2 | 2 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Test/Control | Control/Test |
|---|---|---|
| Study Termination | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.
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.
| Characteristic | Unit | All Enrolled Subjects |
|---|---|---|
| Participants analysed | 4 | |
| Age, Continuous | Years | 29.25 (SD 7.847) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 1 |
| Race/Ethnicity, Customized: White | Count of Participants | 3 |
| Race/Ethnicity, Customized: Asian | Count of Participants | 1 |
| Region of Enrollment: United States | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Posterior Eyelid Temperature (Palpebral Conjunctiva), measured over 12-minutes post treatment.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Celcius |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is posterior eyelid temperature at the palpebral conjunctiva, reported as a mean with standard deviation and measured 12-minutes post treatment. The palpebral conjunctiva is the inner surface of the eyelid, which is relevant to the study’s stated interest in temperature near the meibomian glands. The record describes the outcome unit as Celcius.
The rationale in the record discusses temperature as a possible marker of heat reaching the inner eyelid. It states that ocular surface temperature is usually 34.03±0.51ºC in the normal eye. It also states that the temperature required to melt obstructive secretions in the meibomian glands ranges from 32- 35°C, while more severely obstructed glands could require a temperature of >40°C. These are background statements in the outcome description, not results from this study.
The description further notes an approximate 5°C difference between heat applied to the external eyelid and heat reaching the inner surface, attributing the difference to heat dissipation and blood flow. It states that achieving 40°C at the palpebral conjunctiva would require maintaining at least 45°C on the outer eyelid surface, which the description characterizes as potentially uncomfortable and a risk for thermal injury. Measuring inner-eyelid temperature therefore addresses whether heat reaches the stated target area. The registry record does not report the measured means or standard deviations for either device.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record establishes that a small randomized device evaluation was registered and that posterior eyelid temperature was designated as its primary outcome. It does not establish what temperatures were observed. Although enrollment is recorded as 4, there are no outcome values, arm-level summaries, treatment contrasts, confidence intervals, or p-values in the registry record. The analysis count is 0. As a result, there is no reported estimate from which to judge the size, direction, or precision of a difference between MiBo ThermoFlo and Bruder Mask.
The outcome description specifies a mean and standard deviation, but naming a summary measure is not the same as reporting the observed summaries. Without those values, readers cannot assess how variable the measurements were or how much the data from the two conditions overlapped. Without an estimated within-participant contrast, the direction and magnitude of any difference are also unknown. The record does not report whether the primary endpoint was analyzed as a paired comparison, despite its contralateral description.
The study status is terminated, but that status alone does not explain whether the planned measurements were completed, why the study ended, or whether the results were considered unusable. The registry defines the intended primary-outcome population as subjects completing all study visits without a protocol deviation affecting a primary endpoint. It does not report how many participants qualified under that definition. Enrollment cannot be treated as the number with analyzable endpoint data.
The safety entries list 4 at risk in each group and 0 serious events, 0 other events, and 0 deaths for each group. These counts are descriptive and do not substitute for temperature results or a treatment comparison. The record does not give event terms or further safety detail.
In general, a confidence interval would describe the range of values compatible with an estimated treatment contrast under the analysis assumptions; its width would communicate precision. No such interval is reported. A p-value would summarize how incompatible the observed data are with a specified null hypothesis under a statistical model; no test result or analysis plan is reported. Neither statistical significance nor clinical importance can be assessed from the registry entries alone. The appropriate reading is therefore limited: the trial’s intended question and some design and safety details are documented, but its primary comparative result is not reported in the registry record.
9. Statistical Methods Explained
The registry identifies randomized allocation, no masking, and a contralateral study description with two treatment sequences. Randomization is generally used to reduce systematic differences in treatment assignment. In a contralateral design, each participant can contribute measurements under both treatment conditions, one associated with each eye. This can allow a comparison that accounts for stable characteristics shared by the participant. It also means that the paired measurements are statistically related. These are general design principles; the registry record does not state the randomization procedure or report how the analysis handled paired observations.
What does the endpoint summary represent?
The primary endpoint is continuous: posterior eyelid temperature, summarized as a mean with standard deviation at 12-minutes post treatment. A mean describes the central value of a set of measurements. A standard deviation describes their spread around that mean. Those summaries can characterize each condition, but a comparative question normally requires an estimate of the difference between conditions and an account of its uncertainty. The registry records the intended summary type but reports no means, standard deviations, contrasts, or uncertainty estimates.
For a contralateral comparison, a paired analysis commonly focuses on within-participant differences. In general, analyzing those differences can use the fact that measurements from the same participant are related. Treating them as independent when they are correlated can misstate uncertainty. The appropriate method depends on the data structure and analysis assumptions. No statistical method, model, or handling of within-participant correlation is reported in the registry record, so it would be inappropriate to attribute a particular paired test or model to this study.
What would uncertainty and significance mean?
In general, a confidence interval around a treatment contrast describes uncertainty in the estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but neither width nor location can be evaluated without a reported estimate and interval. A hypothesis test compares the data with a stated null hypothesis under a statistical model. Its p-value does not measure the probability that a treatment is effective, and it does not convey the size or practical importance of a difference. The record contains no p-value, confidence interval, or inferential analysis.
The enrollment of 4 is too limited, by itself, to establish whether the endpoint could be estimated precisely; actual precision depends on the observed measurements and their variability. Those data are not reported. Enrollment also should not be confused with the number included in the primary analysis, because the outcome population is defined by visit completion and absence of a protocol deviation affecting the endpoint. The number meeting those criteria is not reported.
How should planning calculations be read?
The stated sample-size assumptions describe planning illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are hypothetical planning scenarios: they describe sample sizes under specified assumptions and are not observed power. They do not indicate that the trial enrolled enough participants, nor do they establish the precision of its results. The registry record does not report the numerical observed effect or a sample-size justification from the trial’s original design. No inference about the study’s original planning rationale should be drawn from the illustrative assumptions.
For time-to-event outcomes, the stated convention would count total events; for other outcomes, it would express participants per arm. This primary outcome is continuous, not time-to-event. However, the design is described as contralateral and the listed sequences are within-participant, while the planning assumptions refer to equal allocation between two arms. The record does not explain how that convention maps to the contralateral study structure. The registry does not report a protocol-level sample-size calculation, target effect, or justification.
What can be concluded from the posted analyses?
The analysis count is 0, and the record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This means no single reported comparison can be described as the primary numerical result. The absence of a posted analysis is not evidence that the treatments produced identical temperatures. It means the record does not give the estimates needed to characterize a difference, its uncertainty, or a test of a null hypothesis. Any quantitative claim about efficacy or the comparative temperature response would go beyond what the registry record reports.
10. Multiplicity, Missing Data and Analysis Populations
The record lists one outcome measure, but notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not specify which categories or time points are involved, how they were ordered, or which comparison was intended to carry the principal inferential claim. The analysis count is 0. No multiplicity adjustment, hierarchy of hypotheses, or prespecified selection rule is reported in the registry record.
In general, when several outcomes, time points, or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase if the tests are treated independently and no adjustment is made. Multiplicity procedures or a prespecified hierarchy can address that issue, but the appropriate approach depends on the planned questions. No particular approach can be attributed to this study from the registry information.
The record defines the primary-outcome population as subjects who completed all study visits and had no protocol deviation impacting a primary endpoint. It does not report how many enrolled subjects completed the visit, how many were excluded for protocol deviations, or how many contributed measurements to each condition. Missing measurements, reasons for missingness, and methods for handling missing data are not reported in the registry record.
The record also does not state whether the intended analysis was based on all randomized subjects, the defined endpoint population, or another group. This distinction matters because exclusions after randomization can affect interpretation. No assumptions or sensitivity analyses for missing data are reported. The termination status does not establish whether data were missing or why the study ended.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Test | 0 | 4 | 0.0% |
| Control | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test | 0 of 4 |
| Control | 0 of 4 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Test | 0 of 4 |
| Control | 0 of 4 |
The safety record lists a Test group and a Control group. For each, 4 participants are recorded as at risk for serious events and 4 as at risk for other events. Both groups report 0 serious events, 0 other events, and 0 deaths. No serious-event terms are listed. These are the recorded counts, not estimates of comparative risk.
The risk denominators are the number recorded as at risk in each group. The record does not explain whether the group counts represent separate participants, eyes, or treatment exposures in this contralateral study, so they should not be added to infer a total number of unique people. Enrollment is recorded as 4, while the at-risk count is 4 for each group; the record does not explain that accounting further.
In general, observing no events in a small group does not establish that an event cannot occur or that the groups have equivalent safety. The amount of uncertainty depends on the number observed and the study’s follow-up and event ascertainment. The study is described as a single-visit evaluation, and the record does not provide additional safety follow-up details or event definitions. These safety counts should be read as a limited description of events recorded for this study, not as proof of absence of risk or a comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The registry record identifies a specific measurement question: posterior eyelid temperature at the palpebral conjunctiva 12-minutes post treatment, in a randomized evaluation of MiBo ThermoFlo and Bruder Mask. It also provides the study’s rationale for measuring temperature at the inner eyelid and describes the intended primary-outcome population. These details clarify what the investigators sought to assess.
However, the registry does not report the measured temperatures, variability, treatment contrast, or statistical analysis. It therefore cannot show whether one condition produced a higher or lower measured temperature, how large any difference might have been, or how precise an estimate would be. The absence of a reported comparison must not be interpreted as no difference. Nor can the background temperature values in the outcome description be treated as trial observations: they are rationale, not results from the enrolled participants.
The record also does not establish whether the measurement reached a particular temperature threshold or whether any observed temperature would have been clinically meaningful. Such interpretations would require actual results and a clear relationship between the measurement and the intended clinical question. No treatment recommendation follows from the registry entries.
The terminated status is relevant context but does not by itself explain the missing results. The reason for termination and the extent of completed data collection are not reported in the registry record. The safety entries record no serious events, other events, or deaths in the listed groups, but these small descriptive counts do not establish comparative safety.
Overall, the record supports a description of the study design, endpoint rationale, and recorded safety counts. It does not support a conclusion about the comparative temperature effect, clinical benefit, or treatment safety. Those questions remain unanswered in the posted registry information.
13. Why This Trial Matters Statistically
This trial is statistically notable because its stated contralateral design creates a within-participant comparison, while its registry model is labeled parallel. That combination makes the underlying data structure important: measurements from two eyes of the same participant are not automatically independent. Clear reporting of the analysis unit and the method used to account for paired observations would be needed to interpret an estimated contrast and its uncertainty. The registry record does not report those analysis details.
The enrollment is 4, and the registry reports no analyses. With no outcome summaries or comparison, the record illustrates the difference between a registered research question and a reported statistical result. A named endpoint, rationale, and design do not supply an estimate of effect. Without a contrast and uncertainty measure, readers cannot evaluate magnitude or precision.
The stated endpoint rationale also shows why measurement location and timing matter. The outcome is temperature at the palpebral conjunctiva, not external eyelid temperature, and it is specified at 12-minutes post treatment. The distinction is central to the research question, because the record’s rationale describes a difference between heat applied externally and the temperature reaching the inner lid. Yet no observed temperatures are posted to connect that rationale to study data.
Finally, the note that the primary outcome has several categories or time points but was not reduced to one comparison underscores the importance of prespecified estimands and transparent reporting. When multiple outcome dimensions exist, readers need to know which comparison answers the central question and how uncertainty and multiplicity were handled. Those details are not reported in the registry record. The statistical significance of this record lies less in a result than in the limitations of what can be inferred from an incomplete set of posted analyses.
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 interpretation is the absence of reported endpoint results. The registry gives no temperature means, standard deviations, treatment contrast, confidence interval, or p-value. It records 0 analyses, so the comparative primary question cannot be answered from the posted information.
Enrollment is recorded as 4, but the record does not report the number completing the single visit or the number meeting the defined primary-outcome population criteria. It also does not report how many measurements were available for each treatment condition. The study’s terminated status is recorded, but the reason and its consequences for data collection or analysis are not reported in the registry record.
The record describes a contralateral design and randomized treatment sequences, while also labeling the model parallel. It does not clarify that combination or state how the analysis accounted for within-participant correlation, eye-level measurements, or treatment sequence. Masking is listed as none, and no further procedures for measurement or bias control are described.
The primary outcome is noted as having several categories or time points, but the record does not identify them or report one reduced comparison. Details of the statistical plan, multiplicity handling, missing-data methods, and analysis populations beyond the endpoint-population definition are not reported. The safety counts are also limited: each group has 4 at risk, with 0 serious events, 0 other events, and 0 deaths, but the record does not clarify how group denominators relate to unique participants in the contralateral design. These limitations preclude broad conclusions about comparative performance or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: MiBo ThermoFlo Lid Temperature Evaluation — NCT03787212.
- Registry record last updated 2020-02-05; status last verified 2020-01.
- Results first posted 2020-02-05.
- 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.
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18. Record Summary
The registry record describes NCT03787212, MiBo ThermoFlo Lid Temperature Evaluation, as a randomized, unmasked, single-site, single-visit evaluation. It lists MiBo ThermoFlo and Bruder Mask in two contralateral treatment sequences. Enrollment is recorded as 4; the study began on 2018-12-06, reached primary completion on 2019-01-28, and is listed as terminated.
The primary outcome is mean posterior eyelid temperature at the palpebral conjunctiva, measured 12-minutes post treatment. The analysis count is 0, and no outcome estimates or comparative statistical results are reported. The safety entries list 4 at risk in each group, with 0 serious events, 0 other events, and 0 deaths in each. The reason for termination and the results of the primary comparison are not reported in the registry record.