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 Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension (NCT01489670), a registered phase not stated study. The primary outcome is Intraocular Pressure (IOP) at Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01489670 |
| Phase | Phase not stated |
| Condition | Glaucoma, Open-Angle, Ocular Hypertension |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 387 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Patients diagnosed with primary open-angle glaucoma or ocular hypertension and treated in routine clinical practice. The registry lists an enrollment of 387. The primary endpoint population is described as participants with complete data available for intraocular pressure.
Intervention
Lumigan® 0.01%, identified in the record as bimatoprost 0.01% ophthalmic solution. Treatment was given as part of clinical practice rather than under a randomized allocation described in the record.
Comparator
No concurrent comparator is described. The record lists a Lumigan® 0.01% treatment group and says allocation was not stated. The design therefore does not provide a like-for-like control comparison.
Primary question
The registered primary measure is intraocular pressure at baseline, measured in the left and right eye and expressed in mm Hg. It describes pressure at the start of observation; by itself, it does not measure a change during treatment or establish a comparative treatment effect.
The study objective was to assess efficacy, safety, tolerability, and persistence of Lumigan® 0.01% use among patients with either diagnosis who were treated according to routine clinical practice. The listed secondary measures address physician and patient evaluations of efficacy or tolerability, physician-reported reasons for early discontinuation, and continued treatment after 12 weeks.
The study is observational, and the registry does not describe a randomized assignment or a control group. Its clinical question is consequently descriptive: what baseline pressure and other recorded outcomes were observed among treated patients? It cannot, from the design information reported, isolate how outcomes would differ under another treatment or in the absence of treatment. Numerical results for the primary measure and listed secondary outcomes are not reported in the registry record.
3. Trial Design
The registry describes an observational study of Lumigan® 0.01% treatment for patients with primary open-angle glaucoma or ocular hypertension. The study status is COMPLETED, and enrollment is listed as 387. The record identifies Allergan as the sponsor, gives a start date of 2011-09, and lists primary completion as 2013-03.
The treatment group is described as patients with either diagnosis who received Lumigan® 0.01% in clinical practice. The intervention is named as bimatoprost 0.01% ophthalmic solution. Allocation is not stated, and the registry’s design note identifies the study as not being a randomized comparison. No like-for-like control arm is described. This matters because outcomes in a treated observational group can be described, but the design information alone does not establish what would have occurred under a different treatment or without treatment.
The primary outcome is intraocular pressure at baseline. The registry says pressure was measured in the left and right eye, with the endpoint expressed as a median and full range in mm Hg. The primary population is participants with complete data available for this measure. The outcome timeframe is baseline, rather than a specified follow-up change.
Secondary outcome measures cover physician evaluation of efficacy using a 5-point scale, patient evaluation of treatment tolerability using a 4-point scale, physician evaluation of tolerability, physician-reported reasons for early discontinuation, and the number of patients continuing treatment after 12 weeks. The record lists 7 outcome measures and 0 analyses. Numerical results for these measures are not reported in the registry record.
The registry does not report the recruitment procedures, eligibility criteria in detail, treatment duration for the full cohort, visit schedule, or the methods used to assess and handle missing data. These omissions limit how fully the observed group and its follow-up can be characterized from the record.
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: Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice. There was no investigational drug administered in this study.
Overall Study
| Stage | Lumigan® 0.01% |
|---|---|
| STARTED | 387 |
| COMPLETED | 334 |
| NOT COMPLETED | 53 |
Analysis population for the primary outcome, as defined in the registry: All participants with complete data available for IOP.
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 | Lumigan® 0.01% |
|---|---|---|
| Participants analysed | 387 | |
| Age, Customized: 18 to 30 Years | Participants | 1 |
| Age, Customized: 31 to 40 Years | Participants | 3 |
| Age, Customized: 41 to 50 Years | Participants | 28 |
| Age, Customized: 51 to 60 Years | Participants | 53 |
| Age, Customized: 61 to 70 Years | Participants | 113 |
| Age, Customized: 71 to 80 Years | Participants | 120 |
| Age, Customized: 81 to 90 Years | Participants | 62 |
| Age, Customized: >=91 Years | Participants | 5 |
| Age, Customized: Missing data | Participants | 2 |
| Sex: Female, Male: Female | Participants | 237 |
| Sex: Female, Male: Male | Participants | 150 |
6. Primary Endpoint
The registry lists the primary outcome as Intraocular Pressure (IOP) at Baseline, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | mm Hg |
| Endpoint classification | not reduced to a single comparison |
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. The primary endpoint is IOP at baseline, expressed in mm Hg. The registry states that measurement was taken in both the left and right eye and that the endpoint is summarized using a median and full range. The population specified for this endpoint is participants with complete IOP data.
IOP is a clinically relevant measurement in a study of glaucoma or ocular hypertension because it quantifies eye pressure. As a general statistical point, a baseline measurement can describe the starting distribution of a characteristic in the observed group. It does not, on its own, show whether that characteristic changed during treatment. A change endpoint would require measurements at defined times and a stated comparison of those measurements; such a primary change measure is not listed in the record.
The median is the central value after measurements are ordered. It can be useful when a distribution is skewed or has unusually high or low observations, because it is less affected by extreme values than the mean. The full range describes the lowest and highest observed values, but it does not show how values are distributed between those endpoints. These are general properties of the summary statistics, not claims about the shape of this study’s IOP data.
The registry record does not report the baseline median or range values. It also does not report separate numerical summaries for the left and right eye. Without those results, the endpoint’s observed level and spread cannot be assessed from the record. Baseline IOP should not be interpreted as evidence of treatment benefit or harm, and it does not support a causal comparison in the absence of a described control group.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study’s stated purpose is broad: to assess efficacy, safety, tolerability, and persistence of Lumigan® 0.01% use in routine clinical practice among patients with primary open-angle glaucoma or ocular hypertension. The available record describes an observational treatment group, but it does not report numerical results for the primary IOP endpoint or the listed secondary outcomes. As a result, the clinical outcomes cannot be quantified from the registry information.
The primary endpoint is baseline IOP, summarized as a median and full range. This is a description of pressure at baseline among participants with complete data. It is not a measure of change after starting treatment. Even if baseline values were available, they would characterize the enrolled group rather than establish what treatment caused. Numerical values are not reported in the registry record, so neither the central baseline pressure nor its range can be assessed.
The secondary outcome descriptions indicate the kinds of information the study intended to collect: physician assessments of efficacy and tolerability, patient assessment of tolerability, early-discontinuation reasons, and continuation after 12 weeks. The registry does not report the results for these measures. Their names and scales do not reveal how participants responded, how many discontinued, or how many continued treatment.
The observational design also limits causal interpretation. Treatment occurred in clinical practice, and allocation is not stated. The record does not describe a concurrent control group or a randomized comparison. In general, outcomes in an observational treatment group may reflect patient characteristics, clinical decisions, follow-up patterns, and other influences alongside treatment. Without a suitable comparison and an analysis that addresses those factors, the observed outcomes cannot isolate a treatment effect.
The registry lists 387 enrolled participants. This enrollment figure does not by itself establish how many contributed complete data to each endpoint, since the primary population is specifically defined by complete IOP data and endpoint-specific denominators are not reported. Nor does enrollment establish the extent or completeness of follow-up. Those details are not reported in the registry record.
Safety information is limited as well. The record lists 0 serious adverse events among 387 at risk in the treatment group and lists 148 under other adverse events. The serious-event count is an observed count, not proof that the underlying risk is zero. The record does not provide serious adverse-event terms, and deaths are not reported. Definitions, event timing, and further detail about the other-event figure are not available in the registry information.
The registry records 7 outcome measures and 0 analyses. This indicates that outcome measures are listed without corresponding analysis records in the registry. It does not justify assuming that no analyses were performed outside the registry, nor does it reveal the statistical methods used for any unlisted analyses. The registry record does not report estimates, confidence intervals, or hypothesis-test results for the endpoints.
Overall, the record establishes the study’s observational purpose, treatment context, outcome definitions, and selected enrollment and safety counts. It does not provide the numerical efficacy, tolerability, or persistence results needed to characterize outcome magnitudes or precision. The evidence that can be interpreted from this record is therefore primarily about the study design and reporting, rather than an estimated treatment effect.
9. Statistical Methods Explained
The registry identifies an observational study rather than a randomized comparison. That distinction guides the interpretation of every statistical summary. In a randomized comparison, assignment is designed to make treatment groups comparable on average. Here, allocation is not stated, and the record does not describe a control group. General statistical reasoning therefore supports describing outcomes in the treated group, but not treating those outcomes as a causal contrast with another treatment or with no treatment.
What does the baseline median describe?
The primary endpoint is IOP at baseline, reported in mm Hg, with a median and full range specified. The median is the midpoint of ordered observations: it gives a central location while being relatively resistant to extreme measurements. The full range gives the observed minimum and maximum. As a general matter, a range can be sensitive to unusually low or high values and does not convey the concentration of observations around the median. No numerical median or range is reported in the registry record, so these properties explain the proposed summary rather than describe the study’s measured distribution.
The endpoint states that IOP was measured in both eyes. Measurements from the left and right eye belong to the same participant and should not automatically be treated as independent observations in an analysis. This is a general statistical consideration when measurements are clustered within people. The registry does not report whether eye-specific summaries or a participant-level summary were used in any analysis, and it does not report the numerical results for either eye.
What can a confidence interval contribute?
In general, a confidence interval expresses the uncertainty around an estimate under a specified statistical model and sampling process. It can show which values are reasonably compatible with the observed data and assumptions. An interval’s width reflects precision: wider intervals indicate less precise estimation, while narrower intervals indicate greater precision. A confidence interval does not correct a poorly chosen endpoint, missing data, confounding, or lack of a meaningful comparison. The registry record does not report confidence intervals for the outcomes described.
A hypothesis test and a confidence interval address related but distinct questions. A test evaluates compatibility with a specified null hypothesis under its assumptions; a confidence interval displays a range of plausible parameter values under its assumptions. Neither should be interpreted without knowing the analysis population, outcome definition, model, and handling of missing data. No hypothesis-test results or analysis methods are reported in the registry record.
Why does over-dispersion matter?
As a general concept, over-dispersion occurs when count data vary more than a simple model assumes. If that extra variation is ignored, standard errors can be too small and confidence intervals or tests can appear more certain than warranted. Models that allow additional variation may be appropriate for some count outcomes, depending on the data and design. The registry record does not report a count-data model, an over-dispersion assessment, or an analysis requiring such a model. This concept is relevant only as general guidance, not as a description of a method used in this study.
How should the planning illustrations be read?
The planning assumptions describe illustrations based on an observed effect, not the study’s own design. They specify 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 stated fraction of the observed effect. For time-to-event tables, the stated quantity is the total number of events using the Schoenfeld approach; other tables are expressed as participants per arm. These are generic planning assumptions, not evidence that the observational study enrolled randomized arms or was designed around those calculations.
Because the registry describes no like-for-like control comparison, a two-arm planning illustration should not be read as a reconstruction of this study’s actual design. A sample-size calculation is a planning aid that depends on assumptions about the effect, variability, allocation, and analysis. It is not an observed result and is not observed power. The registry does not report a protocol-based sample-size justification or a statistical plan; those details are not reported in the registry record.
More generally, power is a design property under specified assumptions, not a retrospective measure of whether a result is trustworthy. A non-significant result, if one were reported, would not by itself show equivalence or absence of an effect. Conversely, a statistically significant result would not establish causality or clinical importance. The registry provides no test results, estimates, intervals, or analysis details with which to make those assessments for this study.
What does the registry’s analysis listing tell us?
The registry lists 7 outcome measures and 0 analyses. The outcome descriptions identify intended measures, but they do not supply numerical estimates or reveal how each measure was analyzed. The absence of analysis records in the registry means the registered record does not document the analysis methods or results. It should not be expanded into a claim that no analyses occurred in any setting.
Good interpretation requires matching the summary to the design and the data: a baseline median describes a distribution, a confidence interval describes precision under assumptions, and a planning calculation describes a hypothetical design scenario. None substitutes for an observed follow-up contrast. In this record, numerical endpoint results and statistical analyses are not reported, so the main statistical task is to recognize what the defined outcomes could describe and where the available record stops.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures, including the primary baseline IOP measure and secondary assessments of efficacy, tolerability, discontinuation, and continuation. When several outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately without accounting for the collection of tests. General approaches to multiplicity include prespecifying a primary outcome, adjusting test thresholds, or treating secondary analyses as exploratory. Which approach was used in this study is not reported in the registry record.
The registry records 0 analyses. It therefore does not provide analysis results or identify a multiplicity procedure. No interim analysis plan or statistical analysis plan is reported. It would not be appropriate to infer that analyses were or were not adjusted based only on the listed outcome measures.
For the primary IOP endpoint, the stated population is participants with complete data available for IOP. That defines who contributes to that endpoint, but it does not explain how many had complete measurements or why data might be missing. The registry does not report missing-data methods, imputation, sensitivity analyses, or endpoint-specific denominators. The same information is not reported for the secondary outcomes.
Missingness can affect interpretation when participants with observed data differ systematically from those without data. As a general principle, complete-case summaries can be biased if inclusion depends on characteristics related to the outcome. This is a limitation to consider, not evidence that such bias occurred in this study. Without details on follow-up and missingness, the extent and direction of any impact cannot be assessed from the registry record.
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 |
|---|---|---|---|
| Lumigan® 0.01% | 0 | 387 | 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 |
|---|---|
| Lumigan® 0.01% | 148 of 387 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Lumigan® 0.01% |
|---|---|---|
| Conjunctival hyperaemia | Eye disorders | 75 of 387 |
| Eye irritation | Eye disorders | 46 of 387 |
| Eye pruritus | Eye disorders | 27 of 387 |
The registry’s treatment-group safety figures list 387 at risk for serious adverse events and 0 affected by serious adverse events. For other adverse events, it lists 387 at risk and 148 affected. These are posted counts for the group; the registry record does not provide further numerical detail, event timing, or a breakdown of the other adverse events.
A count of 0 serious adverse events means that none were recorded in the listed group under the registry’s reporting. It does not establish that the underlying probability of a serious event is zero. In general, an observed count is subject to the size and follow-up of the observed group, as well as event definitions and ascertainment. The record does not describe those details sufficiently to quantify how they affect interpretation.
The record does not list serious adverse-event terms. Deaths are not reported, so the blank death figure should not be interpreted as a reported count of zero. The figures also do not establish whether the 148 other adverse events are unique event types, repeated events, or otherwise categorized; that detail is not reported in the registry record. These safety counts should be read descriptively, not as a comparative estimate of safety, because no control group is described.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was an observational study of Lumigan® 0.01% use in patients diagnosed with primary open-angle glaucoma or ocular hypertension in routine clinical practice. It describes an enrollment of 387, a baseline IOP endpoint, several secondary measures, and selected safety counts. Those features help identify the study’s intent and the outcomes it sought to assess.
The record does not report the numerical baseline IOP results or the results of the secondary outcomes. It therefore does not show the observed pressure distribution, how physicians or patients rated efficacy or tolerability, what reasons were given for early discontinuation, or how many continued treatment after 12 weeks. Numerical estimates and their precision are not available in the registry record.
The design information also does not support a causal treatment conclusion. The study is observational, allocation is not stated, and a concurrent control group is not described. A change over time, even if it were reported, could reflect factors other than treatment. A comparison with a separate group would also require evidence that the groups are sufficiently comparable and an analysis that addresses relevant differences. Those comparisons and methods are not reported.
The adverse-event counts provide a limited descriptive safety record: 0 serious adverse events among 387 at risk and 148 listed under other adverse events among 387 at risk. They do not provide a complete account of event types, severity, timing, or comparative risk. Deaths are not reported. The observed serious-event count should not be taken as proof that serious events cannot occur.
Thus, the record’s main contribution is the description of the observational setting, registered outcomes, and available event counts, not an estimate of treatment effect. It cannot establish efficacy, comparative safety, or persistence results without the missing outcome data and analysis details. No medical conclusion should be drawn from the absence of reported numerical efficacy results.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of how design determines the questions a dataset can answer. A treatment used in routine clinical practice can yield descriptive information about patients, measurements, tolerability assessments, and recorded events. But an observational group without a described comparator cannot by itself provide the same causal contrast as a randomized comparison. Recognizing that boundary is essential when interpreting clinical evidence.
The choice of a baseline IOP median and full range illustrates the difference between a defined endpoint and an available result. The measure is clearly described, including its units, timing, eyes assessed, and population definition. Yet numerical results are not reported in the registry record. A precise endpoint definition cannot substitute for the estimate and its uncertainty.
The listed secondary measures also illustrate the value of separating outcome domains. Physician assessments, patient assessments, discontinuation reasons, and treatment continuation address different aspects of the study’s stated objective. They should not be collapsed into a single claim about efficacy or tolerability. The record identifies these domains, but does not report their results.
Safety counts need similar care. The serious-event count is zero in the registry listing, while other adverse events are also recorded. These figures are descriptive; without event definitions, follow-up detail, and a comparator, they cannot establish comparative safety or rule out risk. The unreported death figure is not equivalent to a zero count.
Finally, the record lists outcomes without analysis records. This makes transparency about the distinction between a planned measure, an observed estimate, and an inferential conclusion especially important. The study can be characterized from its design and reporting, while conclusions about outcome magnitude, precision, and causality remain unavailable from the registry record.
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 central limitation is that the registry describes an observational treatment group and no like-for-like control comparison. Allocation is not stated. The record therefore does not document a randomized contrast or a concurrent group against which the outcomes could be compared. Even descriptive changes over time, if available, would not alone distinguish treatment effects from other influences.
The primary endpoint is baseline IOP rather than a listed change from baseline. Its stated summary is a median and full range, with the left and right eyes measured. Numerical baseline results are not reported, and the record does not explain whether eyes were analyzed separately or how within-participant correlation would be handled in any analysis. These details limit interpretation of the measure and its statistical precision.
Although enrollment is listed as 387, endpoint-specific denominators and follow-up completeness are not reported. The primary population is restricted to participants with complete IOP data, but the extent and pattern of missing data are unknown. The record does not report missing-data methods or sensitivity analyses. Details on recruitment, eligibility criteria, treatment duration, and visit schedule are also not reported in the registry record.
The registry lists 7 outcome measures but 0 analyses. Numerical efficacy, tolerability, and persistence results, estimates of precision, and analysis methods are not reported. The serious adverse-event count is reported, but serious-event terms are absent; deaths are not reported, and the other adverse-event figure lacks further detail in the record.
These limitations describe what the registry record does not establish. They do not demonstrate that the study lacked additional procedures or analyses outside the registry. However, those details cannot be used to strengthen interpretation unless they are documented in the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension — NCT01489670.
- Registry record last updated 2014-03-28; status last verified 2014-02.
- Results first posted 2014-03-28.
- 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
NCT01489670 is a completed observational study sponsored by Allergan, with a listed enrollment of 387. The registry gives a start date of 2011-09 and primary completion date of 2013-03. It concerns Lumigan® 0.01% treatment in routine clinical practice for patients with primary open-angle glaucoma or ocular hypertension.
The primary endpoint is baseline IOP in mm Hg, measured in both eyes and specified as a median with full range among participants with complete data. Listed secondary measures concern efficacy and tolerability evaluations, early discontinuation reasons, and continuation after 12 weeks. The registry lists 7 outcome measures and 0 analyses.
The record describes 0 serious adverse events among 387 at risk and 148 other adverse events among 387 at risk. Serious-event terms are not listed, and deaths are not reported. Numerical endpoint results, statistical analyses, missing-data methods, and a comparator are not reported in the registry record. The study’s design supports descriptive interpretation, not a like-for-like treatment comparison.