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 of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension (NCT02020512), a na phase 4 study. The primary outcome is Change From Baseline in Intraocular Pressure (IOP) in the Study Eye.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02020512 |
| Phase | Phase 4 |
| Condition | Glaucoma, Open-Angle, Ocular Hypertension |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 87 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with primary open-angle glaucoma or ocular hypertension. The registry lists an enrollment of 87 and defines the primary outcome population as the intent-to-treat population, described as all treated patients. The record does not report further eligibility details, such as diagnostic criteria, baseline pressure ranges, or participant characteristics, so the population represented by the enrollment cannot be described more narrowly from this record.
Intervention
The intervention was 0.03% bimatoprost. The regimen is described as 1 drop in the affected eye once daily in the evening for 5 weeks. It could be used as monotherapy or adjunctive therapy. The registry therefore describes a treatment regimen, but does not report how many participants used it as monotherapy or how many used it as adjunctive therapy.
Comparator
This was a single-group study, with no randomized comparison identified in the registry record. The listed allocation is NA and masking is NONE. There is no separate control group described for a like-for-like comparison. Consequently, the record does not provide a randomized estimate of the difference between bimatoprost and another treatment or a control condition.
Primary question
The primary endpoint was change from baseline in intraocular pressure in the study eye, measured in millimeters of mercury at baseline and Week 5. The record explains that a negative change represents a reduction in pressure and a positive change an increase. However, it does not report the mean change, its standard deviation, or an inferential analysis. The clinical question is therefore apparent from the endpoint definition, but the posted record does not show the observed pressure change.
3. Trial Design
This completed phase 4 study evaluated 0.03% bimatoprost in people with primary open-angle glaucoma or ocular hypertension. The registry lists an enrollment of 87. It describes a single-group design rather than a randomized comparison, with allocation recorded as NA and masking as NONE. There is no separate control arm in the record, so interpretation must focus on the treated group rather than a between-group contrast.
The intervention description specifies 0.03% bimatoprost, 1 drop in the affected eye once daily in the evening for 5 weeks. Use could be as monotherapy or adjunctive therapy. The record does not report the distribution of those two use patterns, or further details about concurrent therapy. It also does not report adherence or treatment discontinuation information.
The primary measure was change from baseline in intraocular pressure in the study eye, with baseline and Week 5 identified as the time points. The outcome was defined as a mean and its dispersion as a standard deviation. The population is described as intent-to-treat, meaning all treated patients in the registry wording. The record does not give a more detailed account of how measurements were taken or how participants with missing measurements were handled.
The study is listed as completed. Its start is recorded as 2011-07 and its primary completion as 2012-12. These dates and the design description help place the study, but do not establish what analysis was conducted or what result was observed. The registry record lists one outcome measure and zero analyses. It does not report a control comparison, an inferential statistical plan, or numerical results for the primary endpoint.
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 | 0.03% Bimatoprost |
|---|---|
| STARTED | 87 |
| COMPLETED | 79 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | 0.03% Bimatoprost |
|---|---|
| Adverse Event | 1 |
| Lost to Follow-up | 3 |
| Protocol Violation | 4 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat: all treated patients
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 | 0.03% Bimatoprost |
|---|---|---|
| Participants analysed | 87 | |
| Age, Continuous | Years | 47.3 (SD 18.1) |
| Sex: Female, Male: Female | Participants | 38 |
| Sex: Female, Male: Male | Participants | 49 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Intraocular Pressure (IOP) in the Study Eye, measured over Baseline, Week 5.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Millimeters of Mercury (mmHg) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in intraocular pressure (IOP) in the study eye, expressed in millimeters of mercury. IOP is a measurement of fluid pressure inside the eye. The endpoint compares the recorded pressure at baseline with the pressure at Week 5. The registry defines a negative change as a reduction in IOP and a positive change as an increase.
As a continuous measure, IOP can be summarized by a mean change, which describes the average change in the analyzed group. A standard deviation describes the spread of individual changes around that mean; it is not the same as a confidence interval or a measure of uncertainty in the mean. These are general statistical interpretations of the endpoint’s stated summary measures.
Change from baseline is used to describe how the measured outcome differs over the treatment period within the observed group. In a single-group study, that description is not itself a comparison with what would have happened without the intervention or under another intervention. The registry identifies the endpoint and time points, but does not report its mean change, standard deviation, confidence interval, or test result. Therefore, the endpoint’s definition is available, but its observed result cannot be read from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable continuous outcome: change in IOP from baseline to Week 5 in the study eye. It also specifies the direction of the scale: negative changes represent reductions, while positive changes represent increases. These definitions make clear how a numerical result would be read. However, the record does not include a numerical mean change or standard deviation for this endpoint. It also lists zero analyses. There is consequently no posted estimate from which to describe the size, direction, or precision of the observed change.
The study enrolled 87 participants and is described as a single-group study. That design can describe measurements over time among treated participants, but there is no separate randomized group in this record to serve as a concurrent comparator. A before-and-after change, even if reported, would not by itself establish how much of that change is attributable to the intervention. General statistical interpretation distinguishes within-group change from a comparative treatment effect: the latter requires a suitable contrast and an analysis of that contrast.
The registry names a mean and standard deviation as the outcome summary, but neither value is posted. A standard deviation would describe variation among participant-level changes. A confidence interval, if available, would instead express uncertainty around an estimated quantity under the assumptions of its analysis. Neither a confidence interval nor a p-value is reported in the registry record. No conclusion about statistical significance or precision can therefore be drawn from this record.
The tables, plots, and planning section should be read in light of this absence. They cannot replace a missing endpoint result or create a randomized comparison. Any sample-size figures in a planning section are illustrations, not observed power and not a result of this study. The record’s stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Those planning assumptions do not describe the actual single-group design, and the registry record does not report the study’s own sample-size justification.
In short, the record documents the question, treatment regimen, outcome definition, and enrollment, but does not provide the primary outcome values or an analysis. A careful reading should distinguish those design details from evidence about the observed change. The available registry information supports describing what the study set out to measure, not quantifying its result or comparing it with another treatment.
9. Statistical Methods Explained
The outcome is continuous: it is a numerical measurement of change in intraocular pressure, reported in millimeters of mercury. The registry specifies a mean and standard deviation as the summary measures. Those labels describe how an outcome can be summarized, but they do not reveal the actual values. The mean change and its standard deviation are not reported in the registry record.
What does a mean change describe?
In general, a mean change summarizes the average difference between each participant’s baseline measurement and the later measurement used in the endpoint. Here, the specified time points are baseline and Week 5. The registry says that a negative number indicates a reduction in IOP and a positive number indicates an increase. That direction statement is important when reading any eventual estimate. It does not tell us which direction the observed estimate took, because the result itself is absent.
A group mean can provide a concise description, but it does not show whether every participant changed in the same direction. Individual responses can vary around the average. The standard deviation is a summary of that variability in the observed values. It is not a confidence interval, and it does not by itself indicate how accurately the group mean has been estimated. These are general distinctions; the record does not post either summary for this endpoint.
What would an inferential analysis add?
In general, an inferential analysis can quantify uncertainty about an estimate, for example with a confidence interval, or evaluate a null hypothesis using a statistical test. A confidence interval describes a range of values compatible with the data and the method’s assumptions; it is not a guarantee that the true value lies in that range. A p-value is interpreted in relation to a specified hypothesis and analysis plan, and does not measure the size or clinical importance of an effect. The registry record lists zero analyses and provides no confidence interval or p-value for the primary endpoint. It is therefore not possible to assess inferential evidence from the posted results.
The absence of a comparator also matters. In a randomized comparison, an analysis can estimate a difference between assigned groups, subject to the design and analysis assumptions. In this single-group study, the endpoint is a change within the treated group. General statistical reasoning cautions that observed change over time can reflect factors beyond the intervention, including natural variation and measurement variation. The registry record does not provide a control group that would help separate those influences.
How should the planning illustration be read?
The page includes a sample-size section based on a planning illustration. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. These are planning conventions, not evidence that the trial enrolled two arms or used those methods. The actual study is recorded as single-group, with allocation NA. Planning sample sizes are not observed power, and they cannot establish that a study did or did not have adequate power after the fact.
The record does not report the study’s own sample-size justification, the effect size used in its design, or its statistical analysis plan. It also does not provide endpoint estimates from which readers could independently assess precision. Any planning display should therefore be kept separate from the study’s actual design and absent outcome results. It is a hypothetical illustration under stated assumptions, not an additional finding about the participants.
What cannot be inferred from the record?
There is not enough information to reconstruct a statistical model, check its assumptions, or verify how the endpoint was calculated. The registry record does not report whether analyses adjusted for baseline values, how repeated or multiple measurements were handled, whether there were interim analyses, or how missing endpoint data were treated. These details should not be guessed. Without the outcome values and analysis description, readers cannot evaluate the numerical estimate, its uncertainty, model fit, or sensitivity to analysis choices.
For a continuous outcome, general method considerations include the distribution of participant-level changes, possible outliers, and whether a mean is an appropriate summary for the data. Over-dispersion, in general, means that observed variability exceeds what a chosen model assumes; if relevant, it can make standard errors and uncertainty estimates unreliable unless the method accounts for it. The registry record does not report information that would allow these features to be assessed. They are considerations for analysis, not claims about this study’s data.
Overall, the registry gives a recognizable endpoint framework—a mean change in IOP with standard deviation, measured from baseline to Week 5—but not the numerical observations or inferential methods needed to interpret a result. General statistical concepts explain what the planned summaries and analyses could mean; they cannot fill in the missing study results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one outcome measure, the change from baseline in IOP in the study eye. It does not report a multiplicity strategy, such as a hierarchy of outcomes or an adjustment for multiple statistical tests. Because the record also lists zero analyses, there are no posted endpoint tests whose multiplicity handling can be evaluated. It would be inappropriate to assume that no adjustment was needed or that a particular adjustment was used.
Missing-data handling is not reported in the registry record. The endpoint description names baseline and Week 5, but does not say how participants without a Week 5 measurement were treated, whether any values were imputed, or whether analyses used all available observations. The outcome population is described as intent-to-treat, defined in the record as all treated patients. This label does not, by itself, reveal how missing measurements were handled or how many participants contributed data to the endpoint analysis.
The record’s enrollment is 87, and the safety group lists 87 at risk for both serious and other adverse events. Those counts do not establish the number with an evaluable primary endpoint. The endpoint-specific analysis population and the number with measurements at each time point are not reported in the registry record. No assumption should be made that every enrolled or treated participant had complete data.
These gaps matter because missingness and multiplicity can affect interpretation. In general, missing-data methods rely on assumptions about why values are missing, while multiplicity concerns the increased chance of false-positive findings when several hypotheses are tested. Neither the relevant methods nor the analyses needed to assess them are available. The result is an endpoint definition without a reported analysis population count, missing-data method, or multiplicity approach.
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 |
|---|---|---|---|
| 0.03% Bimatoprost | 0 | 87 | 0.0% |
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 |
|---|---|
| 0.03% Bimatoprost | 67 of 87 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 0.03% Bimatoprost |
|---|---|---|
| Conjunctival Hyperemia | Eye disorders | 67 of 87 |
The safety figures list 87 participants at risk for serious adverse events and 0 with a serious adverse event in the 0.03% bimatoprost group. The same group lists 87 at risk for other adverse events and 67 affected. These are registry counts for the listed group; the record does not provide further detail about the definitions, event timing, participant-level recurrence, or the specific non-serious events.
The serious adverse event count should be read as a count in the recorded group, not as evidence that serious events are impossible or that the regimen is free of risk. A zero count in a study group does not establish that the underlying risk is zero. The record’s deaths value is null, so deaths are not reported in the registry record; a null value should not be read as a reported count of zero. The top serious event terms list is empty, and no serious event terms are provided there.
These figures do not offer a comparative safety estimate because the study is single-group and no control group is listed. The counts describe what the registry reports for this group; they do not establish whether an event was caused by the intervention. The registry record also does not provide enough detail to assess event severity beyond the serious-event category, duration, or the relationship assessment for other events.
12. What the Result Does, and Does Not, Mean
This record establishes that a completed phase 4, single-group study examined 0.03% bimatoprost in people with primary open-angle glaucoma or ocular hypertension. It specifies a regimen of 1 drop in the affected eye once daily in the evening for 5 weeks, either as monotherapy or adjunctive therapy. It also defines the primary endpoint as change from baseline in IOP in the study eye at Week 5, summarized as a mean and standard deviation.
The record does not report the actual primary endpoint result. The mean change and standard deviation are absent, and the registry lists zero analyses. As a result, readers cannot determine the observed direction or size of change, estimate its precision, or assess a test result from the posted record. The endpoint description tells readers how a result would be interpreted, but it is not itself a result.
The single-group design also limits what could be concluded even if a within-group change were available. A change from baseline describes the treated group over time, but without a concurrent comparator it does not isolate the effect attributable to treatment. General statistical interpretation therefore separates an observed before-and-after difference from a causal treatment effect. The record does not provide a randomized comparison with which to estimate a between-group difference.
The safety counts report no serious adverse events among the 87 listed at risk, and 67 participants with other adverse events among 87 at risk. These counts should be interpreted as registry-reported observations in the group, not as proof that serious events cannot occur or as a comparative assessment. The death value is not reported in the registry record.
Accordingly, the available information supports a description of the study’s design, endpoint, regimen, enrollment, and recorded safety counts. It does not support a numerical conclusion about the primary outcome or a comparison of treatment effects. The planning illustrations, where displayed, are not trial outcomes and are not observed power.
13. Why This Trial Matters Statistically
Statistically, this study is a useful example of the difference between a clear endpoint definition and a reportable result. The registry specifies a continuous outcome, its unit, the time points, the summary measures, and the direction of change. Those details describe what an analysis would summarize. But the record does not include the mean change, standard deviation, or an analysis, so the endpoint cannot be quantitatively interpreted from the posted results.
The design also illustrates why the comparison structure matters. This is a single-group study, not a randomized comparison. Within-group change and between-group treatment effect answer different questions. A baseline-to-Week-5 change can describe what was measured in participants over time; it does not supply a concurrent counterfactual comparison. That distinction is essential when readers consider what a study can establish.
The sample-size planning section is another important teaching point. Planning calculations can explore hypothetical requirements under stated assumptions, but they are not observed power and do not reveal whether the trial achieved a particular result. The listed illustration assumptions include equal allocation between two arms, even though the study design is recorded as single-group. Readers should keep the hypothetical planning setup distinct from the actual study design and avoid treating planning numbers as trial findings.
Finally, the outcome analysis, missing-data methods, and multiplicity approach are not reported in the registry record. These omissions prevent readers from reviewing the estimate, its uncertainty, or the robustness of the analysis. The study record is therefore informative about what was intended to be measured and how the treatment was described, while also demonstrating why transparent numerical results and methods are necessary for statistical interpretation.
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 important limitation for interpreting this particular registry record is that the primary endpoint result is not posted. There is no mean change in IOP, standard deviation, confidence interval, or p-value, and the record lists zero analyses. The stated endpoint and its direction are not enough to establish the observed change or its precision.
The single-group design provides no randomized control group in the record. Accordingly, there is no concurrent comparison to distinguish changes over time from the effect of the intervention. The registry lists allocation as NA and masking as NONE. These details identify features of the recorded design, but the record does not explain why this design was selected or report additional procedures that might address bias.
The record does not report participant characteristics, eligibility criteria, baseline IOP values, or the number of participants with evaluable measurements at each endpoint time point. It describes the primary population as all treated patients, but does not give a detailed accounting of missing measurements or exclusions from analysis. These omissions limit assessment of who contributed to the endpoint and how representative the analyzed group may be.
Further statistical details are also absent: the analysis method, missing-data handling, multiplicity strategy, interim analyses, and sample-size justification are not reported in the registry record. The intervention could be monotherapy or adjunctive therapy, but the distribution between those patterns is not stated. The safety figures provide counts but not event terms for the other adverse events or a comparative group. Together, these limits mean that the record supports a design-level description, but not a full evaluation of the outcome estimate, its uncertainty, or its comparative interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension — NCT02020512.
- Registry record last updated 2014-07-21; status last verified 2014-06.
- Results first posted 2014-07-21.
- 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 phase 4, single-group study of 0.03% bimatoprost in primary open-angle glaucoma and ocular hypertension, with enrollment of 87. The regimen was 1 drop in the affected eye once daily in the evening for 5 weeks, as monotherapy or adjunctive therapy. The primary endpoint was mean change from baseline in IOP in the study eye at Week 5, with standard deviation as the stated dispersion measure.
The registry lists zero analyses and does not report numerical results for the primary endpoint. It also does not report the statistical analysis plan, missing-data methods, or multiplicity approach. Serious adverse events are recorded as 0 among 87 at risk; other adverse events are recorded for 67 among 87 at risk. The deaths value is not reported in the registry record. The study has no randomized control group, so the record does not provide a comparative treatment estimate.