Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects (NCT01010282), a randomized na study. The primary outcome is Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90.

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel-group study evaluating the safety, efficacy, and acceptability of two artificial tears against a currently available artificial tear in subjects with dry eye. The registry lists three treatment arms: Artificial Tears Formulation 1, Artificial Tears Formulation 2, and a glycerin and polysorbate 80 based artificial tear. Randomization assigns participants to treatment groups by chance; masking is intended to limit the influence of treatment knowledge on participants’ reports and on study conduct. The registry does not report how randomization or masking was implemented.

The condition under study was Dry Eye Syndrome. The listed enrollment was 288. The study is marked completed, with a start date of 2009-11 and a primary completion date of 2010-04. The phase is listed as NA. These record details describe study status and planning context; they do not provide evidence about the comparative outcome.

The primary endpoint was change from baseline in SESoD score at Day 90. The registry also lists changes from baseline at Day 90 in the Ocular Surface Disease Index total score, tear break-up time, corneal staining, and conjunctival staining severity score. Those measures cover reported symptoms and ocular findings, but the record does not give the group-level results for them.

The primary outcome population is described as intent-to-treat and includes all patients who started the study (randomized). The registry does not report the number of participants analyzed for the primary outcome, the numbers assigned to each treatment group, or details about participant flow after randomization. It also does not report the study’s eligibility criteria or baseline characteristics. Consequently, the design can be described from the record, but the balance of the groups and the extent of follow-up cannot be assessed from the posted information.

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

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat, which includes all patients who started the study (randomized).

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 Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90, measured over Baseline (Day 1), Day 90.

The primary endpoint is change from baseline in the Subjective Evaluation of Symptom of Dryness score at Day 90. The SESoD is a five-point scale: 0 means no dryness, 1 trace dryness, 2 mild dryness, 3 moderate dryness, and 4 severe dryness. The outcome therefore represents a participant’s rating of dryness symptoms rather than a direct measurement of an ocular sign.

The registry describes the endpoint as a mean with standard deviation and states that a negative change from baseline indicates a decrease in dryness. This direction is important for interpreting a reported mean change: a negative value represents a reduction in the symptom score, while the size and precision of a group difference would require the actual group results and an uncertainty estimate. Those primary numerical results are not reported in the registry record.

Patient-reported symptom measures can capture experiences that clinical signs alone may not represent. General statistical context: a prespecified symptom scale can provide a consistent way to record and compare participants’ reported symptoms over time. However, interpreting a group mean does not establish how individual participants experienced change, and a group mean alone does not show whether differences are clinically important. The registry does not report a threshold for an important SESoD change or further details about how the score was collected.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group trial with three artificial tear arms. General statistical context: random allocation is used to reduce systematic differences between treatment groups at the point of assignment. Masking can reduce the influence of treatment expectations on subjective reporting and assessment. A parallel-group design follows participants in their assigned groups rather than switching each participant between treatments. The record does not describe the specific allocation procedure, who was masked, or how masking was maintained.

What does the primary outcome measure?

The primary endpoint is change from baseline in SESoD score at Day 90. The scale ranges from 0, no dryness, to 4, severe dryness, with intermediate values representing trace, mild, and moderate dryness. Change is interpreted according to the registry’s stated direction: a negative change indicates a decrease in the symptom of dryness. The outcome is listed as a mean with standard deviation, so the planned summary concerns the average change and its spread within a group. The record does not report the observed means, standard deviations, or group comparisons.

General statistical context: analyzing change from baseline can describe how scores differ from their initial values by follow-up. A comparison of changes between groups is distinct from a statement that one group changed from its own baseline. A within-group change does not by itself show that a treatment caused the change, because changes may also reflect time, measurement variation, or other influences. The registry’s primary group results and analysis details are not reported, so the comparative effect cannot be evaluated.

How should means and standard deviations be read?

A mean is a measure of the central value of observations. A standard deviation describes variability among observations around that mean. General statistical context: the standard deviation is not the same as the standard error or a confidence interval. The standard error concerns uncertainty in an estimated mean, and a confidence interval expresses uncertainty around an estimate using a stated method. For a comparison, an effect estimate with an uncertainty interval is more informative than separate group summaries alone. No such primary endpoint estimates or uncertainty intervals are reported in the registry record.

The SESoD is a bounded rating scale with ordered categories. The registry characterizes the primary outcome as a mean of a continuous measure, but does not give further analysis details. General statistical context: means can be useful summaries, though their interpretation depends on the scale and distribution of the data. The registry does not report whether the distribution was assessed, whether any adjustment was used, or whether alternative analyses were planned.

What do the planning assumptions describe?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence about the actual trial’s design or its observed statistical power. The trial itself is registered with three treatment arms; a two-arm planning comparison should not be mistaken for the overall trial allocation.

General statistical context: sample-size planning asks how much information a future study might need to detect an effect under specified assumptions. A planning calculation depends on the chosen effect size, variability, error rate, allocation, and analysis method. It is not a measure of the probability that a completed study’s result is true, and it cannot replace the observed estimate and its uncertainty. The registry does not report a sample-size justification for this trial. The primary outcome’s categories or time points are not reduced to one comparison in the posted analysis, so no single primary comparison is available for a recalculated planning illustration.

What can be inferred from the posted analyses?

The registry reports zero analysis records. This means it does not provide statistical analysis entries for interpreting the primary endpoint or secondary outcomes. It does not establish that no analyses were performed; the analysis methods and results are simply not reported in the registry record. There are no posted primary estimates to reproduce, and therefore no recalculated comparison to set alongside a sponsor analysis.

General statistical context: a transparent analysis description would identify the comparison, analysis population, handling of baseline values, missing data, and uncertainty measures. For a trial with multiple arms and outcomes, it would also clarify which comparisons were confirmatory and how the analysis addressed multiple opportunities for a statistically notable result. These details are not reported in the registry record. The available description supports understanding what was intended to be measured, but not how the primary comparison was statistically evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint and four secondary outcomes. The primary endpoint is change from baseline in SESoD score at Day 90; the secondary outcomes are changes in the Ocular Surface Disease Index total score, tear break-up time, corneal staining, and conjunctival staining severity score at Day 90. With several outcomes and treatment comparisons, multiplicity can matter because examining more comparisons creates more opportunities for apparently notable findings by chance. General statistical context: multiplicity procedures can control the overall chance of false-positive conclusions across a defined family of tests. The registry does not report whether such procedures were planned or used, or how comparisons were prioritized.

The record lists zero analysis records and does not report primary or secondary outcome estimates, confidence intervals, or p-values. It also does not report a statistical analysis plan, interim analyses, or a sample-size justification. These absences prevent assessment of the exact analysis strategy and the interpretation framework used for the completed study.

The primary outcome population is described as intent-to-treat, including all patients who started the study (randomized). The registry does not state how missing Day 90 measurements were handled, whether all randomized participants contributed an outcome value, or whether any sensitivity analyses addressed missingness. Participant flow and numbers analyzed for the primary endpoint are not reported in the registry record. General statistical context: missing outcomes can affect estimates if the reasons for missingness are related to participants’ outcomes or treatment assignment. The direction and extent of any such effect cannot be judged without information about missing data and the analysis approach.

The registry description of an intent-to-treat population should not be treated as proof that every randomized participant had an observed endpoint or was included in a particular calculation. It establishes the stated population definition, but the implementation and analysis details are not reported.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: breast cancer (1.0%), nephrolithiasis (1.0%), acute myeloid leukaemia (1.0%), duodenal ulcer (1.0%), abortion induced (1.0%).

The registry reports serious adverse events and other adverse events separately for the three arms. For Artificial Tears Formulation 1, the serious adverse-event risk set is 97, with 2 affected; the other adverse-event risk set is 97, with 28 affected. For Artificial Tears Formulation 2, the serious adverse-event risk set is 95, with 0 affected; the other adverse-event risk set is 95, with 14 affected. For the glycerin and polysorbate 80 based artificial tear, the serious adverse-event risk set is 96, with 4 affected; the other adverse-event risk set is 96, with 37 affected.

These are the registry’s reported counts and risk sets; they are not adjusted comparisons. The record does not provide a statistical comparison of adverse events between groups, definitions or grading details for the other adverse-event category, or further context about event timing. The registry lists breast cancer, nephrolithiasis, acute myeloid leukaemia, duodenal ulcer, abortion induced, and pulmonary embolism among the top serious adverse-event terms, each reported as 1.0%. These terms should be read as listed event categories, not as a complete description of every serious event.

Deaths are not reported in the registry record. General statistical context: adverse-event counts describe events recorded in a trial, but comparisons can be imprecise, especially when counts are small. They do not by themselves establish whether an event was caused by a treatment or whether groups differ reliably in safety.

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

The record establishes that this study was designed to compare two artificial tear formulations with a glycerin and polysorbate 80 based artificial tear in subjects with dry eye. It also defines the primary symptom outcome and several secondary measures. It does not report the primary endpoint’s group results, so it cannot show from the registry record whether symptom scores changed, how groups compared, or how precise any difference was.

The direction specified for the SESoD endpoint is useful for interpreting a result if one is reported: negative change indicates a decrease in dryness symptoms. That definition is not itself a finding. Without group estimates and a comparison, no conclusion about the direction or magnitude of a treatment difference is supported by the posted results.

The same caution applies to the secondary outcomes. Their inclusion indicates that symptoms and ocular measures were planned for assessment, but their results are not reported in the registry record. The listed safety counts provide descriptive information about reported serious and other adverse events, but the record does not provide statistical comparisons or enough context to attribute events to a particular treatment.

General statistical context: a statistically detectable difference and a clinically important difference are not interchangeable. Statistical uncertainty is assessed through estimates and methods such as confidence intervals; clinical importance requires an interpretable threshold or other context about meaningful change. The registry does not report a threshold for important SESoD change, nor the primary estimates needed to assess uncertainty.

Accordingly, the record should not be read as demonstrating that the formulations are equivalent, that one is superior, or that there is no difference. It also does not establish a difference. Those conclusions require outcome results and suitable analyses, which are not reported in the registry record. The appropriate interpretation is limited to the study question, design, endpoint definitions, and descriptive safety figures that are recorded.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a clear endpoint definition is not enough to interpret a clinical comparison. The registry explains the primary symptom scale, the follow-up time, and the direction of change associated with a reduction in dryness. Those details clarify what an outcome estimate would mean. But because the numerical primary results and analysis records are absent, the central comparative question remains unanswered by the posted registry information.

The study also has multiple treatment arms and several outcomes. General statistical context: when a study makes multiple comparisons, readers need to know which comparisons were planned as primary and how the analysis accounted for the possibility of chance findings across tests. The existence of multiple listed measures does not reveal how this was handled. The registry does not report a multiplicity strategy or a detailed analysis plan.

The record’s description of an intent-to-treat population is relevant because analysis populations can affect interpretation. Yet the number analyzed for the primary endpoint, participant flow, and handling of missing Day 90 data are not reported. A population label alone does not show how missing observations were treated or which participants contributed to an estimate.

Finally, the safety counts illustrate the distinction between descriptive event reporting and comparative inference. Counts and risk sets can help readers understand what was recorded in each group, but they do not establish a statistically reliable treatment difference or causation. The registry record is useful for locating the research question and its planned measures, while its missing outcome and analysis results limit what can be concluded statistically.

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.

A key limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. It gives the SESoD scale, the direction of change, and the Day 90 timeframe, but not group means, standard deviations, between-group estimates, confidence intervals, or p-values. The comparative symptom result therefore cannot be assessed from the record.

The registry also lists four secondary outcomes but does not report their results. It does not describe the statistical analysis plan, methods for handling baseline values, multiplicity procedures, interim analyses, or a sample-size justification. The stated planning illustration assumptions do not establish the trial’s own design rationale or observed power.

Further limitations are that participant flow, group sizes for the primary analysis, baseline characteristics, eligibility criteria, and missing outcome data are not reported in the registry record. Although the primary outcome population is described as intent-to-treat, details of how that population was implemented in analysis are absent. The effect of any missing measurements cannot be evaluated.

The safety information is also limited to reported event counts, risk sets, and selected serious adverse-event terms. The record does not give statistical comparisons, event timing, further event definitions, or death counts. These constraints mean that safety figures can be described but not used to establish comparative risk or causality. These limitations concern the information recorded in the registry; they do not establish what may be available elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects — NCT01010282.
• Registry record last updated 2015-08-17; status last verified 2015-07.
• Results first posted 2011-12-13.
• 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, double-masked, parallel-group study of two artificial tear formulations and a glycerin and polysorbate 80 based artificial tear in subjects with Dry Eye Syndrome. Enrollment is listed as 288; the start date is 2009-11 and the primary completion date is 2010-04.

The primary endpoint is change from baseline in SESoD score at Day 90, with negative change defined as a decrease in dryness symptoms. Secondary outcomes cover Ocular Surface Disease Index score, tear break-up time, corneal staining, and conjunctival staining severity. The record does not report numerical outcome results or analysis records. It reports group-specific serious and other adverse-event counts and selected serious-event terms, but does not report deaths. As a result, the registry record supports a description of the study design and measures, but not a statistical conclusion about comparative efficacy.