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 Efficacy and Safety of Bromfenac Ophthalmic Solution (NCT00585975), a randomized phase 2 study. The primary outcome is Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00585975 |
| Phase | Phase 2 |
| Condition | Cataract Surgery |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 568 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Bausch & Lomb Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
The registry record identifies cataract surgery as the condition studied. It reports an enrollment of 568 participants. Further eligibility details, such as age requirements, surgical criteria, or exclusions, are not reported in the registry record.
Intervention
The intervention was bromfenac ophthalmic solution 0.18%. The registry identifies it as a drug but does not report the dosing schedule, duration of treatment, or administration instructions in the information available for this trial.
Comparator
The comparison group received Xibrom 0.09%. The registry lists the two arms but does not report additional arm-specific treatment details in the arm descriptions.
Primary question
The primary outcome title asks for the number of participants with a summed ocular inflammation score (SOIS) of zero at Day 15. The accompanying description instead refers to participants with SOIS of 1, so the registry record is inconsistent about the score defining the endpoint.
In practical statistical terms, the trial asks how many participants in each randomized group met the stated SOIS criterion at Day 15. The recorded counts are 157 of 277 participants in the bromfenac group and 164 of 291 in the Xibrom group. These are group counts and denominators, not an adjusted comparison or a complete account of uncertainty around a treatment contrast.
The trial also lists “Number of Participants That Are Pain Free” as a secondary outcome. The registry record does not include a result for that outcome in the registry record for this analysis. The central question is therefore limited to the reported primary endpoint counts, with the wording discrepancy kept in view. The record does not establish a formal hypothesis, a prespecified contrast, or the clinical meaning assigned to a particular difference between groups.
3. Trial Design
This was a phase 2, randomized, triple-masked, parallel-group trial. The registry reports that 568 participants were enrolled and that the study is completed. The study began in 2007-10, and primary completion was recorded in 2008-07. Bausch & Lomb Incorporated is listed as the sponsor.
The parallel design assigned participants to one of two groups: bromfenac ophthalmic solution 0.18% or Xibrom 0.09%. The posted outcome denominators were 277 in the bromfenac group and 291 in the Xibrom group. The registry labels allocation as randomized and masking as triple, but the identities of the masked parties and the randomization procedures are not reported in the registry record. The allocation ratio and any stratification factors are also not reported.
The primary outcome is recorded at Day 15 and concerns the number of participants meeting an SOIS criterion. The title specifies a score of zero, while the description says “Participants with SOIS of 1.” That difference matters because the endpoint cannot be interpreted unambiguously from the text alone. The score scale is described in terms of cell counts, with zero representing complete absence, and higher values representing increasing amounts of cells. The registry also lists pain-free participants as a secondary outcome, without a posted result in the registry record for this trial.
The registry record does not report the planned sample-size justification, the target effect, the statistical analysis plan, interim analyses, or the handling of protocol deviations. It also does not report the analysis populations, details of participant follow-up, or reasons for missing observations. Those omissions limit how completely the design and conduct can be assessed from the registry record. The posted group counts can be described, but design labels alone do not establish the details of how randomization, masking, or analysis were implemented.
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 | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% |
|---|---|---|
| STARTED | 277 | 291 |
| COMPLETED | 262 | 278 |
| NOT COMPLETED | 15 | 13 |
Reasons for not completing this period:
| Reason | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% |
|---|---|---|
| Withdrawal by Subject | 3 | 3 |
| Lost to Follow-up | 2 | 1 |
| Enrollment met/over-enrolled | 10 | 9 |
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 | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% | Total |
|---|---|---|---|---|
| Participants analysed | 277 | 291 | 568 | |
| Age Continuous | years | 68.8 (37 to 90) | 68.6 (41 to 90) | 68.7 (37 to 90) |
| Sex: Female, Male: Female | Participants | 169 | 154 | 323 |
| Sex: Female, Male: Male | Participants | 108 | 137 | 245 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero, measured over Day 15.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participant |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero,” with a unit of participants and a time point of Day 15. It is a count of participants meeting a score-based criterion, rather than a mean score or a time-to-event measure. The scale description links SOIS values to cell counts: zero means complete absence, and progressively higher score categories represent increasing cell counts and inflammation intensity.
Such an endpoint can be used to summarize how many participants satisfy a defined clinical or examination criterion at a specified assessment time. Focusing on a threshold can make an outcome easier to interpret than a score across multiple levels, but it also makes the exact threshold important. A participant just outside the criterion and a participant with a much higher score may both be counted as not meeting it, even though their underlying scores differ.
There is a material wording inconsistency in this registry record: the endpoint title specifies SOIS of zero, while its description says “Participants with SOIS of 1.” The record does not resolve whether the title or description reflects the intended criterion. The reported counts are therefore best identified using the title while noting that the endpoint definition is uncertain. This ambiguity limits interpretation of what the counts represent.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports 157 participants in the bromfenac ophthalmic solution 0.18% group and 164 participants in the Xibrom 0.09% group as meeting the listed primary endpoint. The corresponding group denominators are 277 and 291. These counts describe the posted results, but they do not by themselves establish the size, precision, or statistical significance of a between-group effect.
The outcome is a count of participants who met a criterion, with group denominators also reported. A comparison of such outcomes ordinarily requires a clearly specified contrast and an appropriate analysis of the groups. The registry entries available for this trial do not include an analysis result, confidence interval, or p-value. The record reports zero analyses in the results information summarized for this outcome, and the outcome is categorized as not reduced to one comparison. Accordingly, there is no sponsor-reported inferential estimate to interpret in the registry record.
The raw counts should not be treated as if they were directly comparable without accounting for the different group sizes. Nor should the counts be converted into percentages or a difference from the figures stated. No such derived calculation is reported in the registry record. Even if a simple unadjusted contrast were calculated from summary data, it would not replace the sponsor’s planned analysis; the planned analysis and its results are not reported in the registry record.
Precision is also unknown. A confidence interval would describe the range of values compatible with an estimate under a specified method and its assumptions. No confidence interval is reported for the primary endpoint in the registry information available for this trial. Without an interval or a comparable measure of uncertainty, the counts alone cannot show how precisely a group contrast has been estimated.
The endpoint definition adds a separate interpretive limitation. Its title specifies SOIS of zero, while its description refers to SOIS of 1. Since the threshold changes who would count as meeting the endpoint, the inconsistency prevents a fully secure interpretation of the counts’ clinical meaning. The registry record does not clarify which wording is correct.
The record lists pain-free participants as a secondary outcome, but no result for that outcome is included in the registry entries. Thus, the numerical evidence addressed is limited to the primary outcome counts. These data describe the recorded group results; they do not, on their own, support a conclusion about treatment benefit, lack of benefit, or comparative safety.
9. Statistical Methods Explained
Randomization, masking, and endpoint analysis address different sources of uncertainty. Randomization assigns participants to groups using a chance-based process and is intended to support comparability between groups at the start of a study. The registry labels this trial randomized, but the sequence-generation method, concealment procedures, and any stratification are not reported in the registry record. The label alone does not show how those procedures were carried out.
Masking is intended to limit the influence of knowledge about assigned treatment on care, assessment, or reporting. This trial is labeled triple-masked. The registry does not identify which people were masked or describe how masking was maintained. As a result, the label supplies a design feature but not enough detail to judge its practical implementation.
What does the endpoint count?
The primary measure is a participant count at a specified assessment time. The registry gives the endpoint title as the number of participants with SOIS of zero at Day 15 and describes a score scale based on cell counts. For the reported result, the group counts are 157 of 277 and 164 of 291. The endpoint description, however, refers to SOIS of 1. This discrepancy affects the definition of who qualifies as an event, so the outcome should not be treated as fully specified without clarification.
In general, a count of participants meeting a criterion can be analyzed as a binary outcome at the participant level: each participant either meets the criterion or does not. A comparison might then estimate a difference, ratio, or other contrast between groups. Those are general analytical possibilities, not methods reported for this trial. The registry record does not state which contrast, model, or test was planned or used.
What would an uncertainty interval mean?
In general, a confidence interval conveys the precision of an estimated contrast by showing a range of values compatible with the data and the method’s assumptions. It does not guarantee that the true effect lies in that range, and it does not replace the need to assess the design and outcome definition. No confidence interval is reported for the primary outcome in the registry entries. The counts therefore offer a descriptive account without an accompanying estimate of comparative precision.
A p-value, when reported, is a measure of how unusual data at least as incompatible with a specified null hypothesis would be under the assumptions of a statistical test. It is not a measure of the probability that a treatment works, nor does it convey the size or importance of an effect. No p-value or test result is reported in the registry information for this primary outcome. It would be inappropriate to infer statistical significance from the counts alone.
Why are the analysis details important?
Analysis choices can affect the estimand, meaning the precise treatment contrast the analysis aims to estimate. For example, an analysis may focus on outcomes among all randomized participants or on a defined subset, and it may handle missing assessments in different ways. The registry entries do not identify the analysis population or missing-data approach. They also do not state whether the primary analysis was adjusted for baseline factors or other covariates. These details are not interchangeable and cannot be inferred from the group counts.
The outcome is classified as a count-other measure and is not reduced to one comparison in the registry summary. No analyses are listed. Consequently, there is no reported sponsor analysis to use as the principal inferential result. The figures can still be described as posted group counts, but they cannot be presented as a formal estimate of an effect or as evidence from a reported hypothesis test.
Over-dispersion is a general concern for count models when the observed variability is greater than the model assumes. It can make standard errors too small if a model ignores the extra variability. That issue is relevant when the outcome is a count with variable rates or repeated counts; it should not be assumed to apply to this participant-level endpoint. Here, the primary measure is the number of participants meeting a criterion, and the record does not report a count-model analysis.
What do planning calculations represent?
Sample-size calculations based on an observed effect are planning illustrations, not observed power. In general, they estimate how many participants per arm might be needed to detect a specified effect under stated assumptions, such as a significance level, allocation pattern, and statistical approximation. They do not show the probability that the completed trial detected a true effect, and they do not recover the trial’s original design rationale. The registry record does not report its own sample-size justification or planning assumptions. No trial-specific sample-size calculation should be attributed to the investigators on the basis of the posted outcome counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome and one secondary outcome, “Number of Participants That Are Pain Free.” It reports two outcome measures in total, but the available results do not include a pain-free participant count. The registry information does not describe a multiplicity strategy, such as a hierarchy of hypotheses or an adjustment for testing several outcomes. It is therefore not possible to determine from this record how the investigators intended to control the risk of false-positive findings across outcomes.
Missing-data handling is also not reported in the registry record. The posted primary endpoint denominators are 277 and 291, but those figures alone do not explain whether all randomized participants were assessed, whether any were excluded from the outcome analysis, or how missing Day 15 scores were handled. The registry entries do not give the number of missing assessments, reasons for missingness, or any imputation approach.
Analysis populations are not identified. The record does not state whether the primary result represents all randomized participants, participants who received treatment, participants with an evaluable Day 15 assessment, or another population. These distinctions can matter because exclusions after randomization can affect how well the groups remain comparable.
The primary endpoint wording is inconsistent between the title and description, and the record does not clarify the intended threshold. Together, absent analysis details, missing-data procedures, and the endpoint ambiguity restrict interpretation. The registry record does not report a prespecified statistical plan or enough information to assess how multiplicity and missingness were addressed.
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 |
|---|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | 2 | 266 | 0.8% |
| Xibrom 0.09% | 3 | 278 | 1.1% |
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 |
|---|---|
| Bromfenac Ophthalmic Solution 0.18% | 13 of 266 |
| Xibrom 0.09% | 19 of 278 |
Most frequent serious adverse event terms
| Event term | Organ system | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% |
|---|---|---|---|
| Skin Necrosis | Skin and subcutaneous tissue disorders | 1 of 266 | 0 of 278 |
| Abnormal Skin Odor | Skin and subcutaneous tissue disorders | 1 of 266 | 0 of 278 |
| Atrial Fibrillation | Cardiac disorders | 1 of 266 | 0 of 278 |
| Anterior Chamber Inflammation | Eye disorders | 0 of 266 | 1 of 278 |
| Upper Abdominal Pain | Gastrointestinal disorders | 0 of 266 | 1 of 278 |
| Kidney Infection | Renal and urinary disorders | 0 of 266 | 1 of 278 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% |
|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | 13 of 266 | 19 of 278 |
Serious events with the highest arm-level rate: skin necrosis (0.4%), abnormal skin odor (0.4%), atrial fibrillation (0.4%), anterior chamber inflammation (0.4%), upper abdominal pain (0.4%).
The registry reports serious adverse events among 266 participants at risk in the bromfenac group and 278 at risk in the Xibrom group. Serious adverse events affected 2 participants in the bromfenac group and 3 in the Xibrom group. The registry also reports other adverse events among those at risk: 13 participants in the bromfenac group and 19 in the Xibrom group. These are participant counts, not a complete comparison of event rates or evidence of a causal relationship.
The serious-event terms listed are Skin Necrosis, Abnormal Skin Odor, Atrial Fibrillation, Anterior Chamber Inflammation, Upper Abdominal Pain, and Kidney Infection, each reported as 0.4%. The registry entries do not identify arm-specific attribution for these listed terms, so they should not be assigned to a treatment group from this information. Death counts are not reported in the registry record.
Safety counts need context. The at-risk denominators differ from the primary outcome denominators, and the record does not explain the difference. It also does not provide event timing, duration of observation, severity grading beyond the serious-event classification, or a formal comparative safety analysis. Small counts can be particularly uncertain, and an event count alone does not establish whether treatment caused an event. These figures describe what the registry records, without establishing a comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The posted primary results identify 157 participants in the bromfenac ophthalmic solution 0.18% group and 164 in the Xibrom 0.09% group as meeting the listed endpoint, with respective denominators of 277 and 291. They describe the recorded counts at Day 15. They do not provide a reported treatment contrast, an uncertainty interval, or a test result in the registry information available for this analysis.
The record does not establish that one treatment is more effective than the other, nor does it establish that the treatments are equivalent. Equivalence or non-inferiority requires a clearly defined statistical framework and prespecified criteria; these are not reported in the registry entries. Likewise, the absence of a reported inferential result should not be read as evidence that there was no difference. The posted counts are descriptive information, not a substitute for a complete analysis.
Interpretation also depends on what counted as a successful endpoint. The primary title uses SOIS of zero, but the outcome description refers to SOIS of 1. Without clarification, it is uncertain which criterion was used to classify participants. The score scale itself is described in terms of cell counts, but the record does not resolve this conflicting threshold language.
The registry lists pain-free participants as a secondary outcome, but no result for that measure appears in the registry record for this trial. Safety information includes serious and other adverse-event counts, but the reported figures do not include a formal comparative analysis or enough detail to establish causality. The record also does not report the analysis population, missing-data approach, or a statistical plan.
Accordingly, the defensible conclusion is narrow: the registry records group counts for the primary endpoint and adverse events, but important details needed for a comparative interpretation are absent or inconsistent. These registry entries do not support medical advice or a claim that either treatment works, fails, or has a particular comparative safety profile.
13. Why This Trial Matters Statistically
This trial illustrates a basic distinction between descriptive results and an inferential comparison. Counts in each randomized group are useful for understanding what was recorded, but they do not automatically quantify how different the treatments are or how precisely that difference has been estimated. A complete statistical interpretation depends on a defined contrast, an analysis method, and a measure of uncertainty.
It also shows why endpoint wording is not a minor editorial detail. A participant count depends on the rule used to classify participants. Here, the title specifies SOIS of zero while the description refers to SOIS of 1. That inconsistency makes it unclear which threshold the reported counts represent. A clear endpoint definition is essential for reproducibility and for judging whether the outcome answers the intended clinical question.
The record’s design labels—randomized, triple-masked, and parallel—describe important features, while leaving procedural detail unavailable. Statistical appraisal needs both: the design structure and the information about how allocation, masking, analysis populations, and missing data were handled. The absence of these details limits what can be inferred from registry results alone.
Finally, the trial demonstrates why safety counts should be read separately from efficacy outcomes and with attention to their denominators. Serious and other adverse-event counts are recorded, but the listed serious-event terms are not attributed to an arm in the registry entries, and no comparative safety analysis is reported. Keeping these limits explicit helps distinguish observed registry entries from conclusions that require additional analysis and reporting.
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.
Several limitations are specific to the available record for this trial. Most importantly, the primary endpoint is inconsistently described: its title specifies SOIS of zero, whereas the accompanying description says participants with SOIS of 1. The record does not clarify the intended criterion, so the exact meaning of the primary counts is uncertain.
The registry reports the group counts and denominators, but no analysis is listed for the primary outcome. There is no reported effect estimate, confidence interval, p-value, or sponsor analysis in the registry record for this trial. The outcome is categorized as not reduced to one comparison, which further limits direct interpretation as a single comparative estimate.
Important design and analysis details are not reported in the registry record. These include the randomization procedures, identities of masked parties, allocation ratio, analysis population, missing-data handling, and statistical analysis plan. The record also does not give the sample-size justification or information about interim analyses. These omissions prevent assessment of whether the posted counts reflect the planned analysis and how robust that analysis might be.
The secondary pain-free outcome is listed but has no result in the registry entries. For safety, the record gives counts for serious and other adverse events, but does not provide a formal comparison, event timing, or arm-specific attribution for the serious-event terms listed at 0.4%. Death counts are not reported in the registry record. These limitations constrain both efficacy and safety interpretation without establishing that unreported procedures or results were absent from the full trial documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Bromfenac Ophthalmic Solution — NCT00585975.
- Registry record last updated 2013-02-15; status last verified 2013-02.
- Results first posted 2011-12-09.
- 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
NCT00585975 is a completed phase 2 randomized, triple-masked, parallel-group trial sponsored by Bausch & Lomb Incorporated. The registry reports enrollment of 568 participants, with study start in 2007-10 and primary completion in 2008-07. The two groups received bromfenac ophthalmic solution 0.18% or Xibrom 0.09%.
The primary outcome is the number of participants with SOIS of zero at Day 15. The registry description instead refers to SOIS of 1, leaving the endpoint definition inconsistent. The posted counts are 157 of 277 in the bromfenac group and 164 of 291 in the Xibrom group. No primary-outcome analysis, effect estimate, confidence interval, or p-value is reported in the registry entries. Pain-free participants are listed as a secondary outcome, without a result.
Serious adverse events affected 2 of 266 participants at risk in the bromfenac group and 3 of 278 in the Xibrom group. The record also reports other adverse-event counts and lists serious-event terms, but does not provide a formal comparative safety analysis. Key details about analysis populations, missing data, and statistical planning are not reported in the registry record.