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 Assess the Safety and Efficacy of a Daily Disposable Contact Lens (NCT01130974), a randomized na study. The primary outcome is Slit Lamp Findings.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01130974 |
| Phase | NA |
| Condition | Myopia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 200 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Bausch & Lomb Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with myopia who were dispensed a study lens. The primary outcome is defined at the eye level, among dispensed eyes meeting the registry’s stated condition of having slit-lamp findings above grade 2. Other participant eligibility details are not reported in the registry record.
Intervention
The intervention was the Bausch & Lomb daily disposable cosmetic tint contact lens. The registry identifies the intervention as a device and describes the study objective as assessing safety and efficacy.
Comparator
The comparator was a currently marketed daily disposable cosmetic tint contact lens. The registry identifies this as a device, but does not report further details about the marketed lens.
Primary question
Over follow-up visits through 1 month, how many eyes in each arm had qualifying slit-lamp findings, using the worst finding recorded over those visits? The registry reports zero in each arm, with 99 eyes listed for each outcome group. It does not post a comparative effect estimate or an inferential analysis for this outcome.
The registry describes a randomized, parallel-group comparison without masking. Its objective is framed around both safety and efficacy, while the posted primary outcome is a count of eyes meeting a threshold for specified slit-lamp findings. These are distinct aspects of the study: the primary outcome is not a general measure of every possible safety or efficacy feature of a lens. Secondary outcomes named in the record include lens wettability, lens deposits, lens centration, lens movement, and symptoms and complaints. The record does not provide results for those outcomes in the registry record for this analysis.
3. Trial Design
This was a randomized, unmasked, parallel-group device study. The registry lists an enrollment of 200 and identifies myopia as the condition. The study compared a Bausch & Lomb daily disposable cosmetic tint contact lens with a marketed daily disposable cosmetic tint contact lens. The registry lists the study as completed, with a start of 2010-04 and primary completion of 2010-06.
Random allocation means assignment to the study arms was intended to be determined by a chance-based process; the registry does not describe how the sequence was generated or concealed. The parallel-group structure means the record compares separate arms rather than describing a crossover. Masking is listed as none, so the record does not indicate that participants, investigators, or outcome assessors were masked. Further detail about who knew the assigned lens and how outcome grading was conducted is not reported in the registry record.
The primary outcome is expressed in eyes, while enrollment is expressed as a study total. The registry lists 99 eyes in each primary-outcome arm and 100 participants at risk in each arm for adverse-event summaries. These are different reported denominators and should not be treated as interchangeable. The record does not explain how the enrolled participants correspond to the eye-level outcome groups or the adverse-event groups.
The listed primary follow-up window extends through 1 month. The registry names five secondary outcome topics and reports eight outcome measures overall. The protocol, visit schedule, allocation ratio, eligibility details beyond myopia, and the rationale for the planned enrollment are not reported in the registry record. In particular, the posted record does not establish whether the enrollment target was based on a formal sample-size calculation.
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: Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study
Overall Study
| Stage | Bausch & Lomb Contact Lens | Marketed Daily Disposable Contact Lens |
|---|---|---|
| STARTED | 100 | 100 |
| COMPLETED | 85 | 87 |
| NOT COMPLETED | 15 | 13 |
Reasons for not completing this period:
| Reason | Bausch & Lomb Contact Lens | Marketed Daily Disposable Contact Lens |
|---|---|---|
| Protocol Violation | 10 | 10 |
| Withdrawal by Subject | 0 | 1 |
| Ineligibility criteria | 5 | 2 |
Analysis population for the primary outcome, as defined in the registry: All dispensed eyes with any slit lamp findings \> grade 2
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.
Population: All participants were randomized and dispensed lenses at the baseline visit.
| Characteristic | Unit | Bausch & Lomb Contact Lens | Marketed Daily Disposable Contact Lens | Total |
|---|---|---|---|---|
| Participants analysed | 100 | 100 | 200 | |
| Age, Customized: Between 18 and 62 years | participants | 100 | 100 | 200 |
| Sex: Female, Male: Female | Participants | 74 | 76 | 150 |
| Sex: Female, Male: Male | Participants | 26 | 24 | 50 |
| Race/Ethnicity, Customized: Asian Decent | participants | 100 | 100 | 200 |
6. Primary Endpoint
The registry lists the primary outcome as Slit Lamp Findings, measured over Summarized over all follow-up visits through 1 month.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | eyes |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Slit Lamp Findings.” It counts eyes with specified findings graded above 2 over follow-up visits through 1 month. The findings named in the registry are epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. The grading scale runs from 0, none, to 4, severe. The outcome summarizes the worst case over all follow-up visits, rather than reporting a separate result for each visit.
A threshold-based eye count can give a concise account of how many eyes met a defined clinical grading criterion during the observation period. Using the worst finding across visits also means that an eye is represented according to its most severe recorded finding within that period, not by an average across visits. These features can make the outcome easier to interpret than a collection of repeated scores, but they also mean that the count does not show the distribution of grades below or above the threshold, the timing of findings, or which specific finding contributed.
The endpoint is used as the study’s primary measure of slit-lamp findings, not as a complete summary of all lens performance or all possible safety outcomes. Its registry-defined population is all dispensed eyes with any slit-lamp findings above grade 2. The record does not explain the operational details of that population definition or provide a breakdown by finding type.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a value of 0 for Bausch & Lomb Contact Lens and 0 for Marketed Daily Disposable Contact Lens. Each arm lists 99 eyes for this outcome. Thus, the posted result records no eyes meeting the specified primary-outcome criterion in either arm among the listed outcome groups. This description is limited to the endpoint definition, follow-up window, and denominators in the registry record.
The equal reported values do not establish that the lenses are equivalent or that their outcomes are identical in the broader population. The registry does not post an effect estimate, confidence interval, hypothesis test, or other inferential comparison for this outcome. Without an estimate of uncertainty, readers cannot use these posted values to assess how precisely the underlying difference between arms is known. The values also do not show whether findings below the threshold occurred, how grades were distributed, or whether there were differences in the individual types of slit-lamp findings.
The primary outcome uses an eye-level unit, and the record describes the outcome as the worst qualifying case over follow-up visits through 1 month. It therefore should not be read as a count of participants with any possible adverse event, a count of every finding recorded at each visit, or a continuous measure of average severity. The adverse-event summaries are separately reported at the participant level, so their denominators and definitions are not the same as those for the primary outcome.
The record includes a total enrollment of 200, but lists 99 eyes per arm for the primary outcome. The relationship between these figures is not explained in the registry record. It would not be appropriate to infer reasons for the difference, such as exclusions, missing observations, or the number of eyes contributed by each participant.
Because no comparative analysis is posted, there is no sponsor-reported statistical conclusion for this endpoint to interpret. The posted result is descriptive: both outcome groups have a value of zero under the registry’s stated definition. The record does not provide enough information to judge whether this pattern reflects a precise estimate, an outcome that was uncommon, or features of how the analyzed population was defined.
9. Statistical Methods Explained
The registry provides a descriptive primary result but does not post a statistical analysis for the comparison. There is no listed comparative effect estimate, confidence interval, or p-value for the primary endpoint. Consequently, the interpretation is restricted to the arm-level values and denominators, rather than a claim about the strength of evidence for a between-arm difference.
What does a confidence interval communicate?
General explanation: A confidence interval expresses uncertainty around an estimated effect under a specified statistical procedure. A narrow interval indicates greater precision than a wide interval, while an interval that includes no difference may be compatible with more than one interpretation. The registry record does not report a confidence interval for this primary outcome, so the precision of a comparative effect cannot be read from the posted endpoint values alone.
Why is a comparative estimate useful?
General explanation: An arm-by-arm description tells readers what values were reported in each group. A comparative estimate expresses the contrast between groups using a chosen measure, and an uncertainty interval describes how much uncertainty surrounds that estimate. Which measure is appropriate depends on the endpoint and analysis plan. The registry does not report a chosen comparative measure or a method for estimating uncertainty for this outcome. The record’s comparison cannot therefore be reconstructed as a sponsor-reported analysis.
How should the zero values be understood?
General explanation: A zero observed count means that no qualifying outcomes were recorded in the stated analysis group under the defined observation and outcome rules. It does not, by itself, establish that the underlying event cannot occur or that the true risk is exactly zero. Statistical uncertainty can remain even when an observed count is zero. The registry does not post an uncertainty estimate that would quantify it for these results.
The endpoint is a count of eyes meeting a grading threshold, with each eye classified using its worst recorded finding across visits. It is not a mean severity score, and it is not the number of individual findings accumulated across visits. A count-based analysis might use different statistical approaches depending on whether the aim is to compare proportions, event counts, or another summary. The appropriate approach cannot be identified from the registry result alone; the statistical plan and analysis method are not reported in the registry record.
General explanation: Over-dispersion occurs when count outcomes vary more than a model assumes. If present, it can affect standard errors and confidence intervals, so a method that accounts for such variability may be important for some count analyses. The registry does not report a count model, a dispersion assessment, or an analysis of repeated observations for this endpoint. No conclusion about over-dispersion can be drawn from the posted arm-level values.
The registry says the primary outcome summarizes the worst case over visits through 1 month. This definition reduces repeated visit information to an eye-level summary, but the record does not say how incomplete visits were handled or what rules determined whether an eye had an evaluable worst-case value. It also does not describe how the grading was conducted, whether assessors were trained, or whether the grading was independently checked. Those details can matter for an outcome based on clinical grading, but are not reported in the registry record.
The registry’s planning framework describes a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. Such calculations are planning illustrations, not evidence about the observed trial result and not observed power. The registry does not provide a usable comparative effect for this endpoint, and no sample-size values or endpoint-specific planning rationale are reported in the record. The registry’s own design rationale and statistical analysis plan are not reported.
There is no recalculated comparison for this endpoint. The record indicates that values are missing or not estimable for a two-arm comparison of this count-type outcome. Because no recalculated estimate is presented, there is no discrepancy between a recalculation and a sponsor analysis to resolve. If a posted sponsor analysis and a simple recalculation were to disagree, the sponsor’s own analysis would take precedence; that situation is not reported for this endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry names five secondary outcome topics: lens wettability, lens deposits, lens centration, lens movement, and symptoms and complaints. It reports eight outcome measures overall. The record does not state how the primary and secondary outcomes were ordered for statistical testing, whether all measures were intended to be confirmatory, or whether any adjustment for multiple comparisons was planned. A multiplicity strategy is not reported in the registry record.
General explanation: When many outcomes or comparisons are examined, the chance of obtaining a seemingly notable result by chance can increase. Statistical plans may address this through a prespecified hierarchy, an adjustment to significance thresholds, or another approach. Without a stated plan and posted analyses, readers cannot tell whether multiplicity was considered or how it would affect interpretation. No such method should be assumed for this study.
Missing-data rules are also not reported. The record does not explain how eyes without a complete series of visits were handled, how an absent slit-lamp assessment affected the worst-case summary, or whether any imputation was used. It does not provide a flow accounting for enrolled participants and analyzed eyes. The enrollment total is 200, while the primary outcome lists 99 eyes in each arm; the record does not explain the relationship.
The primary outcome population is described as all dispensed eyes with any slit-lamp findings above grade 2. The record does not define a general intention-to-treat population, a per-protocol population, or another analysis population for the primary comparison. No analysis population beyond the endpoint’s own wording should be inferred. These omissions limit assessment of how broadly the posted values represent the randomized groups.
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 Contact Lens | 0 | 100 | 0.0% |
| Marketed Daily Disposable Contact Lens | 0 | 100 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bausch & Lomb Contact Lens | 0 of 100 |
| Marketed Daily Disposable Contact Lens | 0 of 100 |
For the Bausch & Lomb Contact Lens arm, the registry lists 100 participants at risk for serious adverse events and 0 affected. For the Marketed Daily Disposable Contact Lens arm, it also lists 100 participants at risk and 0 affected. The registry likewise lists 100 participants at risk for other adverse events and 0 affected in each arm. These figures describe the posted adverse-event summaries; they are separate from the eye-level primary outcome.
The record does not list deaths as zero: the death fields are null, so deaths are not reported in the registry record in the registry record. No serious adverse-event terms are listed. The absence of listed terms should not be interpreted as a detailed account of event ascertainment or follow-up. The registry does not describe definitions, collection procedures, severity grading, relatedness assessment, or how missing safety information was handled.
General explanation: “At risk” gives the denominator used for an adverse-event summary, while “affected” gives the number reported with the event category. A zero affected count means no events were posted in that category for the stated group; it does not establish that an event is impossible or that every type of safety outcome was captured. The posted figures should be read within their stated categories and denominators, not as proof about all potential harms.
12. What the Result Does, and Does Not, Mean
The result establishes what the registry reports for its primary endpoint: zero eyes in each listed arm met the specified slit-lamp threshold, with 99 eyes listed in each outcome group. The primary endpoint uses the worst-case finding across follow-up visits through 1 month and covers the findings named in the registry. This is a descriptive account of those recorded values.
The result does not establish that the lenses have the same underlying outcome, that the observed difference is precisely zero, or that either lens is safer or more effective overall. No comparative estimate or uncertainty interval is posted for the primary endpoint. Equal observed values are not a formal equivalence or non-inferiority conclusion; such conclusions depend on a prespecified design and analysis, neither of which is reported for this endpoint.
Nor does the primary result summarize every possible eye finding, lens characteristic, or symptom. Findings below the threshold are not described by this count, and the registry does not give results separated by individual slit-lamp finding. The named secondary outcomes are not represented by the primary value. The adverse-event counts are another distinct summary, with participant-level denominators rather than the eye-level primary-outcome denominators.
The trial record documents randomization and a parallel comparison, but does not report the allocation procedure, masking of assessors, analysis populations, missing-data methods, or the statistical plan. Those gaps mean the posted result cannot answer questions about how these design and analysis choices might affect a comparative estimate. The relationship between the total enrollment and the eye-level outcome groups is also not explained.
The appropriate statistical reading is therefore narrow: the registry reports the same observed primary-outcome value in each arm under its stated endpoint definition. The precision and broader comparative meaning of that result are not reported in the registry record. It should not be extended to outcomes, populations, follow-up periods, or conclusions that the record does not document.
13. Why This Trial Matters Statistically
This study illustrates why the endpoint definition matters as much as the numerical result. The primary outcome is not simply “eye safety”: it is a count of eyes meeting a specific grade threshold for a set of slit-lamp findings, using the worst finding across visits through 1 month. That definition determines what the zero values mean and what they leave unmeasured.
It also illustrates the distinction between descriptive results and statistical evidence about a comparison. The registry reports zero in each arm, but does not report a comparative estimate or its uncertainty. Equal values are easy to notice, but the absence of an interval or inferential analysis leaves the precision of any underlying contrast unquantified. A reader should not substitute an informal conclusion for a missing statistical analysis.
The difference between eyes and participants is another important statistical detail. The primary endpoint is expressed in eyes, whereas adverse-event summaries are expressed using participants at risk. Enrollment is reported separately, and the registry does not reconcile these counts. Recognizing the unit of analysis helps prevent denominator confusion and unsupported comparisons across outcome types.
Finally, the record separates an endpoint’s observed value from the design and analysis information needed to interpret it fully. Randomization and a parallel-group design are reported, but key details about allocation, missing data, analysis populations, multiplicity, and the statistical plan are not. These omissions do not change the posted values; they limit how much can be inferred from them. This is a useful example of why a result should be read alongside its endpoint definition, denominator, follow-up window, and analysis details.
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 primary result is available only as an arm-level value and denominator. The registry does not post an effect estimate, confidence interval, p-value, or other statistical comparison for the endpoint. Precision and comparative uncertainty therefore cannot be assessed from the reported result.
The endpoint’s population wording and denominators are not fully explained. The record defines the outcome population as dispensed eyes with any slit-lamp findings above grade 2, while each arm lists 99 eyes and the overall enrollment is 200. The record does not clarify how these figures relate, how many participants contributed eyes, or whether any observations were excluded or unavailable.
The outcome combines multiple specified findings and uses the worst case over follow-up visits through 1 month. No separate results by finding, visit, or grade distribution are reported. The registry also does not detail assessment procedures, grading consistency, handling of incomplete visits, or missing-data rules. Consequently, the posted counts do not reveal the timing or pattern of findings.
Important design and analysis details are absent from the registry record, including the randomization procedure, allocation concealment, assessor masking, analysis populations, statistical method, multiplicity handling, and sample-size justification. The registry lists no analysis entries. The safety summaries also have limited detail: no serious adverse-event terms are listed, and death information is not reported as a numerical result. These limitations constrain interpretation without changing what the record reports.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens — NCT01130974.
- Registry record last updated 2013-12-10; status last verified 2013-11.
- Results first posted 2013-12-10.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed randomized, unmasked, parallel-group study of a Bausch & Lomb daily disposable cosmetic tint contact lens compared with a marketed daily disposable cosmetic tint contact lens. Myopia is listed as the condition, enrollment is 200, and the study dates are 2010-04 to 2010-06.
The primary outcome is the number of eyes with specified slit-lamp findings graded above 2, summarized by the worst finding over visits through 1 month. The registry reports 0 for each arm, with 99 eyes listed per arm, but no comparative estimate or analysis is posted. Serious and other adverse-event summaries each report 0 affected among 100 at risk per arm. Deaths are not reported as numerical results in the registry record.
Five secondary outcome topics are named, and the record reports eight outcome measures overall. Details about the statistical plan, missing-data methods, analysis populations, and sample-size justification are not reported in the registry record.