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 A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution (NCT01024751), a randomized na study. The primary outcome is Comfort-related Symptoms/Complaints.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01024751 |
| Phase | NA |
| Condition | Ocular Discomfort |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 312 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bausch & Lomb Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
Contact lens wearers using silicone hydrogel or Group IV lenses were eligible for the study. The registry record reports an enrollment of 312 participants and says that the primary outcome summaries included eligible participants who received a study product. It does not give further eligibility details or explain how many enrolled participants contributed to each outcome summary.
Intervention
The intervention was Bausch & Lomb Multi-Purpose Solution, described as a solution for disinfecting contact lenses. The study objective was to evaluate its clinical performance when used by the specified contact lens wearers.
Comparator
The comparator was Ciba's Multi-Purpose Solution, also described as a solution for disinfecting contact lenses. Participants were assigned to study products in a randomized, parallel design; the registry record says summaries were organized under the products participants received.
Primary question
The primary outcome concerned comfort-related symptoms or complaints, rated on a 0 to 100 scale for each eye. A 0 was the least favorable rating and a 100 was the most favorable. The record does not report the arm-level ratings or a statistical comparison, so it does not establish how the recorded ratings differed between the products.
3. Trial Design
The registry record describes a randomized, single-masked, parallel study of Bausch & Lomb Multi-Purpose Solution and Ciba's Multi-Purpose Solution. Both products were intended for disinfecting contact lenses. The study objective was to evaluate the clinical performance of the investigational solution compared with the Ciba solution among wearers of silicone hydrogel or Group IV contact lenses. The record lists an enrollment of 312.
The study is marked completed. Its recorded start was 2009-11, and its primary completion was 2010-01. The phase is listed as NA. The registry record names Bausch & Lomb Incorporated as sponsor. These descriptive details establish the setting and broad design, but do not explain how the randomization sequence was generated, how treatment assignments were concealed, or what single masking meant in practice. Those details are not reported in the registry record.
The primary outcome was comfort-related symptoms or complaints. Participants rated each eye on a 0 to 100 scale, with higher values representing more favorable ratings. The stated timeframe included the dispensing visit and follow-up visits at week 2 and week 4. The record also identifies slit lamp findings as a secondary outcome. It does not report numerical results for either outcome or explain the procedures used to assess slit lamp findings.
The primary outcome population is described as eligible, dispensed participants, summarized under the study products received. The registry record does not describe additional analysis populations, participant flow, or the number of participants with outcome data at each visit. Randomized allocation and the parallel structure describe the intended comparison, but the available record does not provide enough detail to assess how closely the analysis followed the randomized assignments.
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.
Before assignment: 312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.
Enrolled Participants
| Stage | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution |
|---|---|---|
| STARTED | 156 | 156 |
| COMPLETED | 153 | 152 |
| NOT COMPLETED | 3 | 4 |
Reasons for not completing this period:
| Reason | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution |
|---|---|---|
| Ineligible at baseline | 3 | 4 |
Eligible Participants
| Stage | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution |
|---|---|---|
| STARTED | 153 | 152 |
| COMPLETED | 153 | 149 |
| NOT COMPLETED | 0 | 3 |
Reasons for not completing this period:
| Reason | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution |
|---|---|---|
| Withdrawal by Subject | 0 | 1 |
| Lost to Follow-up | 0 | 1 |
| Ineligible | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Summaries included all eligible, dispensed participants, with participants summarized under the study products received.
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 | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution | Total |
|---|---|---|---|---|
| Participants analysed | 153 | 152 | 305 | |
| Age, Customized: Between 18 and 70 years | participants | 153 | 152 | 305 |
| Sex: Female, Male: Female | Participants | 102 | 112 | 214 |
| Sex: Female, Male: Male | Participants | 51 | 40 | 91 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 14 | 15 | 29 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 7 | 6 | 13 |
| Race (NIH/OMB): White | Participants | 131 | 126 | 257 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 5 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Comfort-related Symptoms/Complaints, measured over At dispensing visit and each follow-up visit at week 2 and week 4..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns participants’ subjective comfort-related symptoms or complaints while using the assigned contact lens solution. Ratings were made for each eye on a 0 to 100 scale. The direction is important for interpretation: 0 represented the least favorable rating, while 100 represented the most favorable rating. Thus, higher ratings indicate more favorable reported symptoms on this measure.
The registry record specifies assessment at the dispensing visit and at follow-up visits at week 2 and week 4. It also describes an “Over All Follow-Up Visits” summary as the average over all follow-up visit summaries. The outcome is reported as a mean with standard deviation, which describes the group’s average rating and the spread of individual ratings around that average. These summaries would help characterize both typical reported comfort and variability among participants.
Subjective symptom ratings are used to capture experiences that may not be represented by an examination finding alone. They are relevant to the stated objective of evaluating clinical performance, but their interpretation depends on the scale, assessment schedule, completeness of follow-up, and comparison between groups. The registry record does not report the observed means, standard deviations, or a comparative estimate. It therefore does not show the size, precision, or direction of any difference in comfort-related ratings.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and gives its scale, direction, summary measure, assessment schedule, and analysis population. It does not report the actual outcome values or an inferential comparison between products. Consequently, no conclusion about the observed difference in comfort-related symptoms or complaints can be drawn from the recorded primary outcome information. The record also does not include a confidence interval or p-value for this outcome.
The outcome is a mean on a subjective 0 to 100 scale, with higher values indicating more favorable ratings. A mean can describe the group’s central rating, while the standard deviation describes how dispersed ratings are around that mean. Neither measure alone shows whether the product groups differed. A comparative estimate and its uncertainty would be needed to understand the observed difference and how precisely it was estimated. Those statistics are not reported in the registry record.
The study enrolled 312 participants, but the primary outcome summaries were described for eligible participants who received a study product, with participants summarized under the products received. Enrollment does not by itself establish how many participants contributed ratings at each visit. The registry record does not report the group-specific outcome sample sizes, missing ratings, or participant flow. Without those details, it is not possible to determine how much of the enrolled population contributed to each reported outcome summary.
The time structure also matters. Ratings were scheduled at the dispensing visit and at follow-up visits at week 2 and week 4, and the record defines an overall follow-up summary as an average of follow-up visit summaries. The recorded outcome was therefore not described as a single follow-up observation. The registry record does not provide visit-specific values or explain the handling of participants who missed a visit. Since the registry analysis listing contains no analyses, there is no reported comparison to interpret across visits or for the overall follow-up summary.
The safety figures are separate from the primary symptom outcome. The record lists 0 affected participants among 156 at risk in each group for serious adverse events and for other adverse events. These recorded counts describe the safety entries in the registry; they do not supply the missing primary outcome comparison. Deaths are not reported in the registry record.
Planning illustrations based on an observed effect are not evidence about the actual comparative result and are not observed power. The record describes their assumptions as a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It does not report the trial’s own sample-size justification. In the absence of outcome estimates and uncertainty measures, the posted registry information supports a description of the design and measurement plan, but not an assessment of the magnitude or precision of the primary comparison.
9. Statistical Methods Explained
What does the mean describe?
In general, the mean is an average that locates the center of a set of measurements. For this study, the measured quantity was a participant’s rating of symptoms or complaints for each eye on a 0 to 100 scale. The registry record states that 0 was least favorable and 100 was most favorable. An arm-level mean would describe average ratings among the participants included in that arm’s summary. A mean is not a rating that every participant necessarily gave, and it does not show the range of individual experiences.
The record pairs the mean with a standard deviation. In general, standard deviation describes the spread of observations around their mean. A smaller spread means observations tend to cluster more closely around the mean; a larger spread indicates more dispersion. It is not the same as a confidence interval: a standard deviation describes variation among measurements, whereas a confidence interval describes uncertainty around an estimated quantity. No standard deviations or confidence intervals for the primary outcome are reported in the registry record.
How should the visit schedule be understood?
The primary outcome timeframe includes the dispensing visit and follow-up at week 2 and week 4. The registry record separately defines “Over All Follow-Up Visits” as the average over all follow-up visit summaries. In general, repeated assessments can describe how an outcome is observed at different times, while an aggregate across follow-up visits gives a combined summary. These summaries answer different descriptive questions. The registry record does not report visit-specific ratings or the overall follow-up values, and it does not describe the exact calculation beyond that stated averaging summary.
The primary outcome lists a measure at multiple time points, and the registry record does not reduce those observations to a single comparative analysis. It would be inappropriate to treat a particular visit or the overall follow-up summary as the definitive comparison when the record gives no comparative results and no statistical plan specifying which estimate was primary for inference.
What does a between-group estimate add?
In general, a comparative estimate expresses how the outcome differs between groups. For a continuous measure such as this rating, the comparison could be expressed using a difference between group means, but no such estimate is reported in the registry record. A point estimate alone would not convey precision. A confidence interval gives a range of values compatible with the data and the method used; narrower intervals indicate greater precision than wider intervals. Neither the comparative estimate nor its confidence interval is reported for the primary outcome.
A p-value, when reported, is a measure of how compatible the observed data are with a specified null hypothesis under the chosen statistical model. It is not the probability that the null hypothesis is true, nor does it measure the practical importance of an effect. No primary outcome p-value or testing method is reported in the registry record. The absence of a reported p-value does not establish that groups were the same; it means the registry record does not give that inferential result.
Why can spread and model choice matter?
General statistical methods for continuous outcomes often rely on assumptions about the distribution of measurements and the way variability is represented. If outcomes are more dispersed than a model assumes, uncertainty estimates can be too small and tests can be misleading. This is one reason analysts examine variability and choose methods suited to the data. The record reports a mean and standard deviation as the outcome summary but does not state the inferential model, distributional checks, or any adjustment for clustering of the two eye-level ratings within a participant. Those methods are not reported in the registry record.
Ratings for two eyes from one participant may be related rather than independent. In general, analysis methods need to account for dependence when multiple measurements from one person are included. The record says ratings were made for each eye but does not specify whether the eye-level observations were combined, analyzed separately, or handled using another method. No assumption about that choice can be made from the registry record.
What do the planning assumptions mean?
The record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. In general, a planning calculation estimates the number of participants needed under stated assumptions about the effect to detect and the statistical method. It is a design aid, not a measure of whether a completed study had adequate power after the fact. Sample-size illustrations are not observed power and should not be read as a result of the trial.
The registry record does not report the trial’s own sample-size justification or the assumptions used in its original design. It also does not report a numerical primary outcome effect on which a reader could base a separate interpretation. The stated planning assumptions therefore describe the illustrations, not a documented protocol rationale or a demonstrated result.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome was assessed at the dispensing visit and at follow-up visits at week 2 and week 4, with an overall follow-up summary also described. The registry record lists slit lamp findings as a secondary outcome and records two outcome measures. Multiple outcomes or assessment times can create a multiplicity question: in general, testing many comparisons can increase the chance of at least one apparently unusual result when no difference exists. Statistical plans may address this through a prespecified primary comparison or an adjustment for multiple testing. The registry record does not report a multiplicity plan, adjustment, or hierarchy of comparisons.
Missing data also affect interpretation of repeated outcome measurements. In general, results can be biased if the participants with recorded ratings differ systematically from those without ratings. The primary outcome population is described as eligible, dispensed participants, summarized under the products received. However, the registry record does not report visit-specific denominators, missing outcome counts, reasons for missingness, or the method used to handle missing ratings. It is therefore not possible to assess the completeness of follow-up or the sensitivity of the results to missing data.
The record does not describe an intention-to-treat analysis or another named analysis population. It also does not explain whether participants were analyzed according to random assignment, product received, or another rule beyond stating that summaries were under products received. No interim analyses or detailed statistical analysis plan are reported in the registry record. These omissions leave important aspects of the planned and executed inference unclear, independently of the absent numerical outcome results.
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 |
|---|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | 0 | 156 | 0.0% |
| Ciba's Multi-Purpose Solution | 0 | 156 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bausch & Lomb Multi-Purpose Solution | 0 of 156 |
| Ciba's Multi-Purpose Solution | 0 of 156 |
The registry record lists 156 participants at risk in each product group for serious adverse events and 156 in each group for other adverse events. For both categories, the recorded affected count is 0 in the Bausch & Lomb Multi-Purpose Solution group and 0 in the Ciba's Multi-Purpose Solution group. These are the safety counts entered in the registry for this study.
A count of 0 affected participants in the recorded data should be read as a description of the registry entry, not as proof that an event is impossible or that no event could occur in another setting. The record does not provide further details on adverse-event definitions, collection procedures, event timing, or the duration of safety follow-up. It also does not list any top serious adverse-event terms. Deaths are not reported in the registry record.
These safety entries do not replace the missing primary outcome results. They provide no estimate of the comparative comfort ratings and should not be combined with the symptom scale. The counts should be interpreted within the limits of the recorded at-risk groups and the limited safety detail in the registry record.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of two multipurpose solutions in contact lens wearers and specifies a subjective primary outcome, its scale, direction, summary measure, and assessment schedule. It also records an enrollment of 312 and states that primary summaries concerned eligible, dispensed participants classified under products received. These details explain what the study set out to compare and how comfort-related symptoms were intended to be characterized.
The registry record does not report the primary outcome means, standard deviations, a comparative estimate, confidence interval, or p-value. Accordingly, the magnitude and precision of any difference between the products cannot be assessed from the posted results. Missing comparative results do not demonstrate equality, and they do not establish that one product had more favorable ratings. They leave the primary question unresolved in the registry record.
The outcome reflects participants’ ratings on a scale where higher values are more favorable. It is a subjective measure, not a direct measure of every aspect of clinical performance. The record also identifies slit lamp findings as a secondary outcome, but does not give its results or assessment details. The recorded evidence therefore cannot support a broad claim about all outcomes or all dimensions of performance.
The safety entries list no affected participants for the serious or other adverse-event categories in either group, with 156 at risk in each group. Those entries are limited to what the registry reports and do not establish the absence of risk. Deaths are not reported in the registry record.
Overall, the record is informative about the design and intended outcome measurement, but does not provide the numerical primary results needed to judge the observed comparison. It should not be interpreted as showing either benefit, lack of benefit, equivalence, or a clinically important difference.
13. Why This Trial Matters Statistically
This study illustrates why a clear outcome definition is only part of a statistical result. The registry record specifies that participants rated symptoms or complaints for each eye on a 0 to 100 scale, identifies which end of the scale is least and most favorable, and gives the assessment schedule. Such information helps readers understand what a numerical result would represent and guards against reversing the direction of the scale.
The record also distinguishes the mean and standard deviation as the primary outcome summaries. In general, reporting both central tendency and spread can make a continuous outcome more interpretable than reporting an average alone. Yet descriptive summaries do not replace a comparative estimate and uncertainty interval when the question concerns differences between randomized groups. Those comparative statistics are not reported in the registry record, emphasizing the distinction between describing a planned analysis and reporting its result.
The described population is another statistically important feature. Eligible, dispensed participants were summarized under the products received. This wording is relevant to interpreting the population represented by any summary, but the registry record does not state how it relates to the randomized population or explain the handling of missing visits. Clear reporting of those details would help readers assess attrition and the alignment between assignment and analysis.
Repeated assessments, separate eye ratings, a secondary outcome, and missing-data questions can affect analysis choices. General statistical practice requires these choices to be described so readers can understand what was estimated and how uncertainty was handled. The registry record does not report the relevant analysis plan or a multiplicity approach. Its safety entries are also separate from the primary symptom outcome and do not fill the gap in comparative efficacy results.
The statistical importance of this record is therefore not a numerical claim about which solution had more favorable ratings. It is a case where design and measurement information are available, while the outcome estimates and inferential details needed to assess the primary question are not reported.
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 direct limitation is that the registry record does not report the numerical primary outcome results. Means, standard deviations, between-group estimates, confidence intervals, and p-values are not available in the record. Without them, the observed direction, magnitude, and precision of the comfort-related symptom comparison cannot be evaluated.
The primary outcome was assessed at multiple visits and for each eye, but the record does not explain how eye-level ratings were combined or modeled, or how the repeated observations were handled statistically. It describes an overall follow-up summary, but does not give its values or visit-level results. This limits interpretation of both the measure and its time pattern.
The record identifies eligible, dispensed participants as the population for primary summaries and says participants were summarized under products received. It does not report group-specific analysis counts, participant flow, visit completion, or missing-data handling. The relationship between the randomized groups and the analyzed population therefore cannot be fully assessed. Methods for allocation, masking, outcome assessment, and the statistical analysis are also not described in detail.
The registry record does not report the trial’s own sample-size justification, a multiplicity plan, or interim analyses. It lists slit lamp findings as a secondary outcome but does not provide corresponding results or enough detail to interpret that assessment. Safety reporting is limited to the recorded affected counts; adverse-event definitions and collection details are not reported, and deaths are not reported in the registry record.
These limitations concern what can be learned from the registry record. They do not establish that the study had no findings or that the products were the same. They mean that the recorded information is insufficient to assess the primary comparative result or several aspects of its analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution — NCT01024751.
- Registry record last updated 2011-08-15; status last verified 2011-07.
- Results first posted 2011-08-11.
- 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 a completed, randomized, single-masked, parallel study sponsored by Bausch & Lomb Incorporated. It lists 312 enrolled participants and compares Bausch & Lomb Multi-Purpose Solution with Ciba's Multi-Purpose Solution among wearers of silicone hydrogel or Group IV contact lenses. The recorded start was 2009-11 and primary completion was 2010-01.
The primary outcome was comfort-related symptoms or complaints, rated for each eye on a 0 to 100 scale, with higher scores more favorable. Assessments were planned at dispensing and at follow-up visits at week 2 and week 4; summaries were described as means and standard deviations. Slit lamp findings were listed as a secondary outcome.
Primary outcome values and comparative analyses are not reported in the registry record. The safety entries list 0 affected participants among 156 at risk in each group for serious and other adverse events. Deaths are not reported in the registry record.