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 Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) (NCT01594970), a non-randomized phase 4 study. The primary outcome is Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01594970 |
| Phase | Phase 4 |
| Condition | Glaucoma, Open-Angle, Ocular Hypertension |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | Single |
| Enrollment | 800 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
People with elevated intraocular pressure due to primary open-angle glaucoma or ocular hypertension. The primary outcome population is described as all treated subjects with data at the Week 12 time point.
Intervention
Bimatoprost 0.01%, administered as one drop in the affected eye or eyes in the evening. The record describes use for 12 weeks in three treatment contexts: previously untreated monotherapy, monotherapy after switching from another treatment, and use with adjunctive therapy.
Comparator
No randomized control group is described. The three groups reflect different treatment histories or concurrent therapy, rather than like-for-like groups assigned at random to alternative treatments.
Primary question
What numbers of participants had each recorded level of ocular hyperemia severity in the study eye at Week 12? The outcome is a participant count for each grade on the stated scale, not a reported comparison of treatment effects between randomized groups.
The study is titled as an evaluation of safety and efficacy in primary open-angle glaucoma or ocular hypertension. Its primary outcome focuses on hyperemia, meaning redness from engorgement of the eye’s blood vessels. The registry record also lists change from baseline in intraocular pressure and overall percent change from baseline in intraocular pressure as secondary outcomes. Those outcomes address pressure measurements, while the primary outcome describes an ocular sign.
The central statistical distinction is between describing outcomes in treatment groups and estimating a causal treatment effect. Because allocation is non-randomized and the groups have different prior treatment or adjunctive-treatment contexts, their results would not automatically represent a fair comparison of alternatives. The registry record does not report numerical primary-outcome results or a treatment-effect estimate. It therefore does not establish from the information recorded whether the groups differed in hyperemia or pressure outcomes.
3. Trial Design
This is a Phase 4, non-randomized, single-group study of bimatoprost 0.01%, with single masking recorded. The registry lists enrollment of 800 and describes three treatment groups: naive monotherapy, switched monotherapy, and use with adjunctive therapy. Each group description specifies an evening drop in the affected eye or eyes for 12 weeks. The groups represent different treatment circumstances rather than randomized assignments to comparable alternatives.
The record gives a study start of 2012-03 and primary completion of 2013-01, and lists the status as completed. Allergan is named as sponsor. The conditions are open-angle glaucoma and ocular hypertension. These administrative and design details establish the setting, but do not by themselves indicate what outcomes were observed or how precisely they were estimated.
Non-randomized allocation matters for interpretation. Prior treatment, treatment switching, and adjunctive therapy distinguish the groups by clinical context. Any differences in outcome between them could reflect those contexts or other differences, as well as treatment experience; the record does not describe a randomized comparison that would balance such factors by design. The registry itself cautions that the arms are not a like-for-like control comparison.
Although the study model is listed as single-group, the record presents outcome and safety information by treatment group. That structure should not be mistaken for a randomized multi-arm trial. The record does not report a separate control intervention. It also does not report the detailed statistical plan, allocation procedures beyond the non-randomized designation, or the rationale for the enrollment target. These details are not reported in the registry record.
The main outcome is the number of participants in each ocular hyperemia severity grade at Week 12. The registry also lists two intraocular-pressure outcomes as secondary measures. The reported primary population is all treated subjects with data at that time point, which describes a population definition but does not explain how missing Week 12 measurements were handled.
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 | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) |
|---|---|---|---|
| STARTED | 295 | 248 | 257 |
| COMPLETED | 220 | 166 | 191 |
| NOT COMPLETED | 75 | 82 | 66 |
Reasons for not completing this period:
| Reason | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) |
|---|---|---|---|
| Non-Adverse Event Related | 4 | 5 | 6 |
| Adverse Event | 17 | 23 | 23 |
| Lost to Follow-up | 54 | 54 | 37 |
Analysis population for the primary outcome, as defined in the registry: Intent to Treat: all treated subjects with data at this time point
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 | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) | Total |
|---|---|---|---|---|---|
| Participants analysed | 295 | 248 | 257 | 800 | |
| Age, Continuous | Years | 58.0 (SD 13.81) | 59.5 (SD 13.23) | 61.2 (SD 12.59) | 59.5 (SD 13.30) |
| Sex: Female, Male: Female | Participants | 130 | 145 | 105 | 380 |
| Sex: Female, Male: Male | Participants | 165 | 103 | 152 | 420 |
6. Primary Endpoint
The registry lists the primary outcome as Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale, measured over Week 12.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint records ocular hyperemia severity in the study eye at Week 12. Hyperemia is described as engorgement of the eye’s blood vessels, visible as redness. The registry specifies a five-point scale with grades 0, 0.5, 1, 2, and 3, running from none (normal) through trace, mild, moderate, and severe. The endpoint is reported as the number of participants at each grade.
A graded outcome can preserve distinctions in severity that would be lost if observations were reduced to a simple present-or-absent indicator. Counts by grade can show how observations are distributed across the scale. However, the registry record does not give the actual grade counts, so the distribution and its precision cannot be assessed from the recorded results.
Hyperemia is used as the primary outcome because it is a safety-related ocular sign relevant to the study’s evaluation of bimatoprost. The endpoint does not itself quantify intraocular pressure or establish an overall benefit-harm balance. Pressure change and overall percent pressure change are listed as secondary outcomes, but numerical results for those measures are not reported in the registry record.
The scale’s stated categories define what is being counted, but the record does not report additional details such as assessor procedures, reliability, or how the measure was analyzed beyond presenting counts by severity grade. Those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its measurement scale, but does not report the numerical counts in each hyperemia grade at Week 12. Without those counts, it is not possible to describe the observed severity distribution, compare the groups numerically, or assess the precision of any such comparison. No primary-outcome effect estimate or confidence interval is reported in the registry record.
The secondary outcomes are change from baseline in intraocular pressure and overall percent change from baseline in intraocular pressure. The record lists these measures but does not provide numerical results for them. It therefore does not support a quantitative statement about the size, direction, or precision of pressure changes. The study’s title and objectives do not substitute for outcome data.
There are safety counts recorded by group. For serious adverse events, the registry lists 1 of 295 participants in naive monotherapy, 0 of 248 in switched monotherapy, and 1 of 257 with adjunctive therapy. For other adverse events, it lists 7 of 295, 9 of 248, and 14 of 257, respectively. These are descriptive group figures. They should not be interpreted as randomized comparative estimates, because allocation was non-randomized and the groups differ in treatment context.
The registry also lists serious adverse-event terms of Glaucoma at 0.4% and Lung Neoplasm Malignant at 0.3%. The record does not provide enough detail in the listed details to determine how those terms relate to the group-level counts or to establish causal attribution. The death fields are null, so death counts are not reported in the registry record; null should not be read as confirmation of zero deaths.
With no reported analysis records, no p-values, confidence intervals, or adjusted treatment comparisons are available in the registry record. The available safety counts can be described, but they do not show whether apparent differences are beyond sampling variation or reflect differences in group composition. No conclusion about efficacy or comparative safety can be drawn from the recorded numerical information alone.
The enrollment value of 800 is a registry design characteristic, not a substitute for outcome-specific denominators or results. The primary endpoint population is defined as treated subjects with data at Week 12, but the record does not report how many participants contributed data to each grade. Nor does it describe the reasons for missing outcome measurements. These omissions limit both interpretation and assessment of precision.
9. Statistical Methods Explained
What does a participant count by grade tell a reader?
A count by severity grade describes how observations are distributed across the categories of an outcome. For ocular hyperemia, the registry defines grades from none through severe and states that numbers of participants in each grade are presented. Such counts can make the observed pattern understandable without imposing a single numerical summary on the ordered categories. But counts alone do not show how much uncertainty surrounds the pattern, and the registry record does not include the actual grade counts or confidence intervals.
In general, a confidence interval expresses uncertainty around an estimated quantity using a range of values compatible with the data and the specified method. A narrower interval generally indicates greater precision than a wider interval. The record does not report confidence intervals for the primary outcome or the listed pressure outcomes, so their precision cannot be evaluated from the registry results.
Why does allocation matter for comparisons?
Random allocation, in general, helps make groups comparable at the start by distributing measured and unmeasured characteristics without a systematic treatment-selection rule. This study is explicitly described as non-randomized. Its groups are defined by whether participants were previously untreated, switched from another monotherapy, or also receiving adjunctive therapy. These contexts can be associated with differences among participants. Consequently, a contrast between groups would be descriptive rather than a clean estimate of what would happen if otherwise comparable participants were assigned to different treatments.
The registry characterizes the arms as not a like-for-like control comparison. That warning is central to interpreting any group-wise safety figures. Even if two groups had different recorded event counts, the difference could reflect their distinct composition or treatment context, and not solely the intervention. No adjusted comparative analysis is reported in the registry record.
What can be said about the analysis plan?
The record lists four outcome measures and no analysis records. It does not report the statistical model, hypothesis tests, confidence-interval method, covariate adjustment, or a prespecified plan for handling multiple outcomes. Those details are not reported in the registry record. Without them, it is not possible to reconstruct a formal analysis or determine whether a reported estimate was planned, adjusted, or exploratory.
The sample-size assumptions described for planning illustrations are not a record of observed power. In general, a planning calculation depends on assumptions about the effect to detect, significance level, allocation, and statistical approximation. Such a calculation is not evidence that the study achieved a particular power after data collection. The registry record does not report a sample-size justification or enough outcome results to interpret an observed-effect calculation as evidence of precision.
Over-dispersion is a general concern when count data vary more than a model assumes. If a count model understates that variability, its uncertainty estimates can be too small and its intervals or tests too optimistic. The primary outcome is recorded as participant counts across severity grades, but the record does not report a count model or any inferential analysis for those grades. It is therefore not possible to say whether over-dispersion was assessed or relevant to the sponsor’s analysis.
How should the safety counts be read?
Event counts and the number at risk provide a descriptive snapshot within each recorded group. They are not, by themselves, a rate over person-time, a risk difference, or an adjusted comparison. The registry lists serious adverse-event counts and other adverse-event counts for the groups, but does not report a comparative model, time-to-event analysis, or uncertainty interval for these figures. The exposure period in the group descriptions is 12 weeks, but the record does not give event timing or participant-level follow-up details.
In general, low event counts can be compatible with substantial uncertainty about the underlying frequency. Comparisons are especially difficult when groups are not randomized and when event definitions, follow-up, and analysis procedures are not fully documented. The recorded counts should therefore be read as descriptive entries, not as proof that one treatment context has greater or lesser risk.
Statistical interpretation also depends on the analysis population. The primary endpoint population is stated as all treated subjects with data at Week 12. This excludes, by definition, treated participants without that time-point data, but the record does not state how missing observations were handled or whether other populations were analyzed. No imputation or sensitivity-analysis approach is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary ocular hyperemia outcome and secondary outcomes for change from baseline in intraocular pressure and overall percent change from baseline in intraocular pressure. It also states that there are four outcome measures, while no analysis records are listed. The strategy for controlling multiplicity across outcomes, severity categories, time points, or treatment groups is not reported in the registry record.
In general, when several outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase if each is interpreted independently. A prespecified hierarchy or adjustment can address that issue, but the registry record does not describe such a plan. No significance tests or analysis results are recorded, so the effect of multiplicity on any findings cannot be evaluated.
The primary population is described as all treated subjects with data at Week 12. That definition indicates that the endpoint uses available data at the stated time point, but it does not explain the amount or pattern of missingness. The number of participants with primary outcome data, reasons for missing observations, and any method for handling missing data are not reported in the registry record.
The record does not identify an intention-to-treat analysis beyond the population wording, nor does it report alternative analysis populations or sensitivity analyses. It is therefore not possible to determine whether the results were robust to different assumptions about missing measurements. These issues matter because the completeness and handling of follow-up data can affect the estimated outcome distribution.
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 |
|---|---|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | 1 | 295 | 0.3% |
| Bimatoprost 0.01% (Switched Monotherapy) | 0 | 248 | 0.0% |
| Bimatoprost 0.01% (With Adjunctive Therapy) | 1 | 257 | 0.4% |
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 |
|---|---|
| Bimatoprost 0.01% (Naive Monotherapy) | 7 of 295 |
| Bimatoprost 0.01% (Switched Monotherapy) | 9 of 248 |
| Bimatoprost 0.01% (With Adjunctive Therapy) | 14 of 257 |
Most frequent serious adverse event terms
| Event term | Organ system | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) |
|---|---|---|---|---|
| Glaucoma | Eye disorders | 0 of 295 | 0 of 248 | 1 of 257 |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 295 | 0 of 248 | 0 of 257 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bimatoprost 0.01% (Naive Monotherapy) | Bimatoprost 0.01% (Switched Monotherapy) | Bimatoprost 0.01% (With Adjunctive Therapy) |
|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | 7 of 295 | 9 of 248 | 14 of 257 |
Serious events with the highest arm-level rate: glaucoma (0.4%), lung neoplasm malignant (0.3%).
The registry lists serious adverse events separately from other adverse events for each treatment group. Serious-event figures are 1 of 295 in naive monotherapy, 0 of 248 in switched monotherapy, and 1 of 257 with adjunctive therapy. Other-event figures are 7 of 295, 9 of 248, and 14 of 257, respectively. These are recorded counts and group denominators, not adjusted comparisons.
Because the study is non-randomized, the groups should not be treated as equivalent controls. Their prior treatment and adjunctive-therapy contexts differ, and the registry does not report a comparative safety model or uncertainty intervals. The counts therefore describe what was recorded in each group but do not establish a difference in risk attributable to treatment.
Glaucoma at 0.4% and Lung Neoplasm Malignant at 0.3% are listed as the most frequent serious-event terms. The record does not report further detail that would support interpretation of causality or timing. Death counts are not reported in the registry record: the relevant fields are null, which does not establish that no deaths occurred.
In general, adverse-event counts are interpreted in light of event definitions, ascertainment, exposure, follow-up, and analysis methods. The registry’s listed figures do not supply all those details. They should be read as descriptive safety information rather than as a complete comparative safety assessment.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase 4 study evaluated bimatoprost 0.01% in people with primary open-angle glaucoma or ocular hypertension, with three treatment contexts and a 12-week treatment description. It identifies ocular hyperemia severity at Week 12 as the primary outcome and lists intraocular-pressure measures as secondary outcomes. Those are descriptions of the study’s scope, not evidence of a particular outcome.
The numerical primary endpoint results are not reported in the registry record. The pressure outcome values are also not reported. Without those observations, there is no basis in the recorded results to state the direction or size of change, how outcomes were distributed, or how precisely an effect was estimated. The study title and the stated objective cannot fill in missing results.
The safety entries show event counts for the three groups, but the non-randomized design limits comparisons. The groups represent different treatment histories or concurrent adjunctive therapy, and the registry does not describe an adjusted analysis that accounts for those differences. The figures cannot establish that an event difference was caused by the treatment or that groups had equal risk.
The findings also should not be generalized beyond the information recorded. The registry does not report detailed eligibility criteria, participant characteristics, adherence, follow-up completeness, or a full statistical analysis plan. The primary outcome population includes treated subjects with data at Week 12, but missing-data methods are not reported. These gaps prevent a full assessment of selection, precision, and robustness.
In general, a study can be informative about the outcomes it measures without providing a definitive causal comparison. Here, the registry record documents the design, endpoints, and some safety counts, but does not provide the principal numerical efficacy results. It therefore supports a description of what was planned and recorded, not a conclusion that bimatoprost did or did not change pressure or hyperemia.
13. Why This Trial Matters Statistically
This trial is statistically instructive because it separates outcome measurement from causal comparison. It records a graded ocular sign and lists pressure outcomes, but its non-randomized allocation means that the three groups are not interchangeable treatment arms. The treatment contexts—naive monotherapy, switched monotherapy, and adjunctive therapy—are part of the interpretation, not incidental labels.
The primary outcome also illustrates the distinction between an endpoint definition and an endpoint result. The registry gives a clear description of the hyperemia scale and says that participant counts by grade are presented. Yet those counts are not reported in the registry record. A precise outcome definition cannot by itself show the observed distribution or its uncertainty.
The safety information offers another useful distinction: descriptive event counts are not the same as comparative risk estimates. The counts are accompanied by group denominators, but the registry does not report adjusted analyses or intervals. In a non-randomized study, comparing those counts without accounting for group context risks treating unlike groups as if they were assigned under the same conditions.
Finally, the record demonstrates why statistical methods and missing-data reporting matter. The endpoint population is defined by availability of data at Week 12, while the amount and handling of missing data are not described. The record lists multiple outcomes but does not report a multiplicity strategy or analysis results. These gaps limit how much can be inferred even when design features and some safety counts are available.
The statistical value of the record is therefore primarily in clarifying the study’s structure and the limits of its evidence. It allows readers to distinguish a treatment evaluation from a randomized comparison and to identify which outcome details are absent from the registry results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting the primary outcome is that the registry record does not report the number of participants in each hyperemia severity grade at Week 12. It defines the scale and the outcome population, but supplies no grade-specific result or uncertainty estimate. Numerical results for the listed intraocular-pressure outcomes are also not reported.
The study is non-randomized, and the registry cautions that the groups are not a like-for-like control comparison. The groups differ by previous treatment or adjunctive therapy. No adjusted comparative analysis is listed, so group-wise event counts should not be interpreted as causal treatment contrasts.
The registry record does not report detailed participant characteristics, eligibility criteria, outcome-assessment procedures, or the extent and reasons for missing Week 12 data. Although the primary population is described as treated subjects with data at that time point, missing-data methods and sensitivity analyses are not reported. The effect of incomplete follow-up therefore cannot be assessed.
The analysis plan is also not reported. There are no analysis records, and the record does not describe statistical models, confidence-interval procedures, multiplicity handling, or covariate adjustment. It does not report a sample-size justification. These omissions make it difficult to assess whether the analyses were prespecified or how uncertainty was handled.
For safety, event counts and listed serious-event terms are available, but details about timing, exposure, ascertainment, and causal assessment are not reported in the registry record. The death fields are null, so death counts cannot be interpreted as zero. These limitations restrict both quantitative comparison and broader inference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) — NCT01594970.
- Registry record last updated 2014-01-28; status last verified 2014-01.
- Results first posted 2014-01-28.
- 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
NCT01594970 is a completed Phase 4, non-randomized, single-group study of bimatoprost 0.01% in primary open-angle glaucoma or ocular hypertension. The registry lists enrollment of 800, single masking, and treatment for 12 weeks across naive monotherapy, switched monotherapy, and adjunctive-therapy contexts. Allergan is named as sponsor; the recorded start is 2012-03 and primary completion is 2013-01.
The primary outcome is the number of participants in each ocular hyperemia severity grade in the study eye at Week 12. Change from baseline and overall percent change from baseline in intraocular pressure are listed as secondary outcomes. Numerical results for these outcomes are not reported in the registry record.
Serious and other adverse-event counts are listed by group, alongside serious-event terms. Since allocation was non-randomized and the groups are not like-for-like controls, these figures are descriptive rather than causal comparisons. The registry record does not report analysis results, a multiplicity approach, or missing-data methods.