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 Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax (NCT02322528), a na na study. The primary outcome is Ocular Surface Temperature of Both Eyes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02322528 |
| Phase | NA |
| Condition | Sjogren's Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Rochester |
| Results posted | Yes |
2. Clinical Question
The registry describes a study in people with Sjogren's Disease examining ocular-surface measures after administration of Lotemax. Its primary outcome is the mean ocular-surface temperature of both eyes, recorded at baseline, 30 minutes, week 1, and week 2. The study also describes collecting inflammatory mediators for laboratory analysis.
Population
Participants with Sjogren's Disease. The registry records an enrollment of 10. Additional eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Administration of Lotemax to both eyes. The arm description identifies 0.5% Lotemax and states that it would be used to induce an inflammatory mediated response.
Comparator
No separate comparator group is registered. The study model is single group, and allocation is listed as NA. Baseline and follow-up measurements are time points, not a like-for-like control group.
Primary question
How does mean ocular-surface temperature change across the registered measurement times in this single-group study? The record does not post numerical temperature results or an analysis answering that question, so the size and precision of any change cannot be described from the registry record.
3. Trial Design
This is a completed, single-group study sponsored by the University of Rochester. The registry lists an enrollment of 10 and the condition Sjogren's Disease. The study started in 2014-04, reached primary completion in 2015-08, and has status COMPLETED. Its phase is listed as NA.
The registered intervention is administration of Lotemax, a drug, to both eyes. The arm description calls it 0.5% Lotemax and says it will be administered to induce an inflammatory mediated response. The registry lists masking as NONE and allocation as NA. There is no registered separate control arm, so the design is not a randomized or blinded comparison. Repeated measurements over time can describe changes within participants, but by themselves do not provide a concurrent untreated comparison.
The primary outcome is ocular-surface temperature of both eyes, with measurements specified at baseline, 30 minutes, week 1, and week 2. The record lists 2 outcome measures, but 0 analyses. It does not report a statistical analysis plan, sample-size justification, interim analyses, or further details about the measurement schedule and procedures. The record's completion status does not establish that every planned measurement was collected or that results were analyzed. The registry does not report a separate comparison group, and the enrolled sample should not be interpreted as evidence of a planned two-arm design.
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
| Stage | Administration of 0.5% Lotemax |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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 | Administration of Lotemax |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 56.7 (SD 4.92) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 1 |
| Region of Enrollment: United States | participants | 10 |
6. Primary Endpoint
The registry lists the primary outcome as Ocular Surface Temperature of Both Eyes, measured over baseline, 30 minutes, week 1, week 2.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | degrees celcius |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean ocular-surface temperature of both eyes. The registry specifies a continuous measure, reports the intended summary as a mean with standard deviation, and labels the unit as degrees celcius. Measurements are scheduled at baseline, 30 minutes, week 1, and week 2.
Temperature is a physical measure of the ocular surface. In general, repeated measurements can be used to describe how a continuous outcome varies over time. The endpoint may be considered alongside the study's stated interest in ocular-surface inflammation, but temperature alone does not directly quantify all inflammatory mediators. The registry description says Lotemax will serve as a vehicle to study changes in inflammatory mediators on the eye surface and to collect mediators for laboratory analysis using Luminex instrumentation and standard ELISA assays.
The registry record does not post the observed means or standard deviations at any time point, nor does it report an estimated change, confidence interval, or test result. It also does not give additional operational details about temperature measurement, such as instrument, measurement conditions, or how measurements from the two eyes would be combined. Those details should not be inferred from the endpoint name.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the question and measurement schedule, but it does not provide numerical outcome results. Although ocular-surface temperature is named as the primary outcome and the record lists 2 outcome measures, it records 0 analyses. There are no posted means, standard deviations, changes from baseline, confidence intervals, or p-values to interpret. Consequently, the magnitude and precision of any observed temperature pattern cannot be assessed from the registry record.
The design also matters to interpretation. This is a single-group study with no separate comparator and no masking. A change between baseline and a later measurement, if reported, would describe a within-group pattern over time. Without a concurrent comparison group, that pattern alone would not distinguish an intervention-associated change from other explanations, such as time-related variation or measurement conditions. This is a general limitation of interpreting uncontrolled before-and-after observations, not a claim about what happened in this study.
The measurement schedule includes baseline, 30 minutes, week 1, and week 2, but the registry does not report whether each participant contributed data at every time point. Nor does it specify how repeated measurements or the two eyes would be handled in an analysis. The completed status indicates registry status, not that outcome data are available for statistical review.
The record's stated laboratory aims concern inflammatory mediators, but no mediator results or analyses are posted. The primary endpoint is temperature, and it should not be treated as a substitute for unreported laboratory findings. Likewise, the stated purpose and planned use of Lotemax do not establish an observed effect. No conclusion about the direction, size, or statistical uncertainty of an outcome can be drawn without the missing numerical results and analysis details.
9. Statistical Methods Explained
The registry identifies a continuous primary outcome summarized as a mean and standard deviation. It does not report the statistical methods used to analyze that outcome. The concepts below explain how such measures are generally interpreted; they do not describe an analysis confirmed in this study.
What does a mean describe?
In general, a mean is a measure of the central value of a set of observations. For a continuous measure such as temperature, it provides a compact description of the observed values at a particular measurement time. A mean alone does not show how individual observations are distributed, whether there are unusual values, or whether the same participants contributed observations at each time point.
What does a standard deviation describe?
In general, a standard deviation describes the spread of observations around their mean. It is not the same as the uncertainty around the estimated mean. A confidence interval, if calculated, would address uncertainty in an estimate under the analysis assumptions; the registry does not report one. Neither a standard deviation nor a confidence interval is posted for the registered temperature outcome.
How do repeated measurements affect analysis?
In general, measurements taken from the same participant over time are related rather than independent. Measurements from both eyes of one participant may also be related. Analyses of repeated observations need to account for the structure of the data if they are to estimate uncertainty appropriately. Possible general approaches include analyzing participant-level changes or using a repeated-measures model, but the registry record does not identify an approach, define the analysis unit, or say how measurements from both eyes would be handled. No particular method should be attributed to this study.
In a single-group study, a within-participant comparison can describe how measurements differ over time. It does not create a randomized control comparison. The observed pattern can be influenced by factors that change over time or by measurement conditions. This is a general interpretive issue for uncontrolled repeated-measure studies; whether any such influence occurred is not reported in the registry record.
What can a test or interval add?
In general, a statistical test evaluates data against a specified null hypothesis under stated assumptions. A p-value is not the probability that a treatment works, and it does not measure the size or practical importance of an effect. A confidence interval gives a range of values compatible with the data and method, and indicates statistical precision. These tools require an estimate, observed data, and an analysis method. The registry reports 0 analyses and posts no such estimates, intervals, or tests for the primary outcome.
Over-dispersion is a general concern when the observed variability is greater than assumed by a statistical model. If a model does not accommodate that variability, its uncertainty estimates may be too small. The registry does not report a model or distributional assessment, so whether over-dispersion is relevant to any analysis in this study cannot be determined.
How should planning calculations be read?
General sample-size planning calculations are conditional illustrations, not results from enrolled participants and not observed power. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. Those assumptions do not match the registered single-group design with no separate comparator. Any such illustration should therefore not be read as the study's actual design or as a registry-reported sample-size justification. The registry does not report the protocol's sample-size rationale. Planning figures also cannot supply the missing outcome estimates or establish what was observed.
More broadly, a complete statistical interpretation would require the outcome data, the analysis population, the handling of missing measurements, the model or comparison used, and measures of uncertainty. These details are not reported in the registry record. The methods are general statistical explanations rather than a reconstruction of an unreported analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and 0 analyses. It identifies ocular-surface temperature as the primary outcome, but does not provide numerical results for it or the other registered outcome. The record does not say whether the outcomes were tested separately, whether any multiplicity adjustment was planned, or how the primary outcome was distinguished from other analyses in practice. Those procedures are not reported in the registry record.
Multiplicity is a general issue when several outcomes, time points, or comparisons are examined. Conducting many tests can increase the chance of observing a nominally unusual result even when there is no underlying effect. Analysis plans may address this by specifying a primary comparison or by adjusting inference, but no such plan is reported. The presence of several registered measurement times does not establish that a particular set of statistical tests was conducted.
The registry does not report the amount or pattern of missing outcome data, whether all enrolled participants completed each measurement, or how missing values were handled. It also does not identify an analysis population, such as all enrolled participants or participants with complete measurements. Without those details, the impact of missingness and the relationship between enrollment and any analyzed sample cannot be assessed. The completed status and enrollment count alone do not establish the number with usable outcome data.
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 |
|---|---|---|---|
| Administration of 0.5% Lotemax | 0 | 10 | 0.0% |
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 |
|---|---|
| Administration of 0.5% Lotemax | 0 of 10 |
The safety record lists 10 participants at risk for serious adverse events and 0 affected. It also lists 10 at risk for other adverse events and 0 affected. No top serious adverse event terms are listed. These figures describe what the registry reports; they do not establish how events were monitored, collected, or classified.
The death count is not reported in the registry record. A blank or unavailable count should not be read as a reported zero. The record also does not provide further detail about observation duration for safety outcomes, event definitions, or the completeness of safety reporting. With an enrollment of 10, the figures should be read as the registry's reported counts in this study, not as a precise estimate of the frequency of uncommon events or as a comparison with another group. No separate comparator group is registered.
12. What the Result Does, and Does Not, Mean
The record identifies a completed study with enrollment of 10 and a primary outcome of mean ocular-surface temperature measured at baseline, 30 minutes, week 1, and week 2. It also describes an interest in inflammatory mediators and ocular-surface metrology after Lotemax administration to both eyes. These details establish what the registry says the study set out to examine.
They do not establish what the measurements showed. No numerical results or analyses are posted for the primary outcome, and the record lists 0 analyses. The available information therefore does not support a description of temperature change, its variability, or the precision of an estimate. The registry's stated purpose is not itself a result, and the named intervention does not establish an observed effect.
The design further limits what could be inferred from a change over time even if outcome values were available. Because the study is single group and has no separate comparator, a before-and-after pattern would not by itself isolate the intervention from other influences. This general design limitation does not mean that a change did or did not occur; it defines the scope of inference available from the registered design.
The registry also does not report mediator results, analysis populations, missing-data handling, or the statistical approach. As a result, the record cannot establish whether the intended laboratory assessments were completed or how they relate to the primary temperature endpoint. The safety counts are reported separately and do not fill the gap in efficacy-related outcome reporting. Overall, the registry supports a description of the study's design and planned measurements, but not a quantitative conclusion about outcome patterns or their statistical uncertainty.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why a registered question and a completed status are not substitutes for posted outcome results. The record specifies a continuous primary endpoint, a measurement schedule, and an intended summary using means and standard deviations. Yet it records 0 analyses and does not post the corresponding numerical estimates. Without those results, readers cannot evaluate either the direction of a pattern or its precision.
The design also illustrates a distinction between repeated measurement and controlled comparison. Recording an outcome at baseline and later times can characterize a within-group trajectory. A separate comparator would address a different question by helping distinguish changes over time from changes associated with the intervention. This record registers no such comparator, so any interpretation must stay within the limits of a single-group design.
There is also a practical issue in planning: the stated sample-size illustration assumes equal allocation between two arms, whereas the registered study is single group. Planning calculations depend on design assumptions and should not be mistaken for evidence about a study's actual analysis or power. They cannot replace the missing outcome data.
Finally, the record's stated interest in inflammatory mediators alongside ocular-surface temperature makes clear why endpoints must be read separately. A temperature measure and laboratory mediator measurements are not interchangeable outcomes. Their relationship would require reported data and analysis. These features make the record a useful reminder to distinguish registered aims, design, safety counts, and actual statistical results.
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 most important limitation for statistical interpretation is the absence of numerical outcome results and analyses. Although the registry lists 2 outcome measures, it records 0 analyses. No temperature means, standard deviations, effect estimates, confidence intervals, or p-values are posted. The size and precision of an outcome pattern therefore cannot be assessed.
The registered design is single group, with no separate comparator, and masking is listed as NONE. These design features limit causal interpretation of any within-group changes. The registry does not provide enough detail to assess the specific measurement procedures, including how measurements from both eyes would be summarized or how repeated observations would be modeled.
Other relevant details are not reported in the registry record: participant eligibility criteria beyond the listed condition, baseline characteristics, the statistical analysis plan, the sample-size justification, missing-data handling, and the analysis population. The record also does not clarify whether all planned time points were measured for all enrolled participants or report mediator results. These are limitations in what can be evaluated from the registry record, not evidence that particular procedures were absent from the conduct of the study.
The safety record reports no affected participants in its serious and other adverse-event categories, but does not report the death count or additional ascertainment details. Those limitations constrain interpretation of the safety information as well.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax — NCT02322528.
- Registry record last updated 2015-10-16; status last verified 2015-09.
- Results first posted 2015-10-16.
- 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 University of Rochester sponsored this completed, single-group study in Sjogren's Disease, with an enrollment of 10. The record lists Lotemax administration to both eyes, no masking, and allocation as NA. The registered primary outcome is mean ocular-surface temperature of both eyes at baseline, 30 minutes, week 1, and week 2.
The registry lists 2 outcome measures and 0 analyses. Numerical outcome results, analysis methods, missing-data handling, and an analysis population are not reported in the registry record. Safety counts list 0 affected participants among 10 at risk for serious events and 0 among 10 at risk for other events; deaths are not reported. The record supports a description of the study's planned question and design, but not a quantitative interpretation of its outcomes.