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 Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT01177098), a randomized phase 3 study. The primary outcome is Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01177098 |
| Phase | Phase 3 |
| Condition | Glaucoma, Ocular Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 561 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients with glaucoma or ocular hypertension. The registry record lists enrollment of 561 participants. The primary outcome description specifies a per-protocol population: randomized participants without a protocol violation considered to have significantly affected trial conduct or results. The number included in that population is not reported in the registry record.
Intervention
Participants assigned to formulation A received one drop in each eye every morning for 12 weeks. This was a fixed combination of bimatoprost and timolol. The registry record does not state the concentration of formulation A.
Comparator
The comparator was bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution, identified in the record as Ganfort®. Participants received one drop in each eye every morning for 12 weeks.
Primary question
The primary endpoint was change from baseline in intraocular pressure in the worse eye at Hour 0, Hour 2 and Hour 8 at Week 12. The worse eye was defined using the higher baseline pressure. The record does not report the group results or a statistical test, so the extent and precision of any difference between formulations cannot be assessed from the posted primary outcome information.
3. Trial Design
This was a Phase 3 randomized, double-masked, parallel-group trial. Its stated purpose was to evaluate the safety and efficacy of bimatoprost/timolol formulation A against the bimatoprost/timolol fixed combination identified as Ganfort® in patients with glaucoma or ocular hypertension. The registry record lists enrollment of 561 participants and status as completed.
The treatment descriptions specify one drop in each eye every morning for 12 weeks in both groups. The comparator concentration is stated as bimatoprost 0.03%/timolol 0.5%; the concentration of formulation A is not reported in the registry record. The trial start is listed as 2010-10 and primary completion as 2012-02. These dates describe the registry record and do not establish when individual participants entered or completed follow-up.
Randomization is intended to distribute participant characteristics across treatment groups by chance, while masking is intended to limit the influence of treatment knowledge on trial conduct and assessment. A parallel-group design assigns participants to a group that receives its assigned treatment rather than crossing between treatments. These are general features of the design; the specific allocation procedure, masking roles, and measures used to preserve masking are not reported in the registry record.
The primary endpoint was defined for the per-protocol population. The number randomized to each group, the number included in the primary analysis, and reasons for exclusion are not reported in the registry record. Detailed statistical methods and a prespecified analysis plan are also not reported there.
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/Timolol Formulation A | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution |
|---|---|---|
| STARTED | 278 | 283 |
| COMPLETED | 269 | 271 |
| NOT COMPLETED | 9 | 12 |
Analysis population for the primary outcome, as defined in the registry: Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.
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/Timolol Formulation A | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | Total |
|---|---|---|---|---|
| Participants analysed | 278 | 283 | 561 | |
| Age, Customized: <45 Years | Participants | 12 | 13 | 25 |
| Age, Customized: 45 to 65 Years | Participants | 132 | 135 | 267 |
| Age, Customized: >65 Years | Participants | 134 | 135 | 269 |
| Sex: Female, Male: Female | Participants | 159 | 162 | 321 |
| Sex: Female, Male: Male | Participants | 119 | 121 | 240 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12, measured over Baseline, Week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mm Hg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in intraocular pressure (IOP) in the worse eye at Hour 0, Hour 2 and Hour 8 at Week 12. IOP measures fluid pressure inside the eye. The worse eye was defined as the eye with the higher IOP at baseline. The endpoint description states that a negative change indicates a reduction in pressure.
Assessing change from baseline expresses the follow-up measurement relative to the participant’s starting measurement. In general, repeated measurements across hours can describe how a treatment-group mean changes at different assessment times rather than reducing the outcome to a single time point. The registry record identifies the mean and standard deviation as the endpoint summary measures. A mean describes the group’s average change; a standard deviation describes how spread out individual changes are around that average.
IOP is the measured outcome because the trial concerns glaucoma or ocular hypertension and its stated objective includes evaluating efficacy. The endpoint definition alone does not establish what the observed changes were or whether the groups differed. The values at the listed assessment times, their uncertainty, and a statistical comparison are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically interpretable measurement and its direction: negative change from baseline means lower IOP. It also specifies the worse eye and the assessment times at Week 12. However, it does not report the mean changes, standard deviations, confidence intervals, p-values, or a treatment contrast for the primary outcome. Consequently, the posted primary endpoint information does not permit an estimate of the size or precision of the difference between formulation A and the fixed combination.
The endpoint includes measurements at Hour 0, Hour 2 and Hour 8. Those are distinct assessments, not interchangeable observations. A result at one hour would not by itself describe the results at the other assessment times. The registry record does not identify one of these time points as a sole primary comparison, nor does it report a statistical procedure for analyzing the set of measurements. The record also lists secondary outcomes for change in worse-eye and average-eye IOP at each hour evaluated at Week 12, adding further outcome comparisons to consider when interpreting any complete results.
When group means and their uncertainty are available, interpretation should consider both the estimated difference and how precisely it is estimated. A confidence interval, in general, gives a range of values compatible with the data under the statistical model and conveys uncertainty around an estimate. No confidence intervals or treatment-effect estimates are reported for the primary outcome in the registry record, so precision cannot be described.
Safety counts are reported separately. Four participants at risk in each group had a serious adverse event; other adverse events were recorded for 59 participants in the formulation A group and 55 in the fixed-combination group. These are descriptive counts, not an adjusted comparison. The registry record does not give a statistical analysis of these safety counts or report the death counts. The counts alone do not establish whether the groups differed in safety.
Thus, the record identifies the trial question, design, endpoint, and some adverse-event counts, but not the primary efficacy results or inferential analysis. Any conclusion about relative IOP changes would require results not reported in the registry record.
9. Statistical Methods Explained
What does a mean change represent?
The primary outcome is continuous: it records a pressure change on a measurement scale rather than classifying each participant into a yes-or-no category. The registry record specifies the mean as the summary measure. In general, a group mean gives the average change for participants included in the analysis. It can be useful for comparing groups, but it does not show how variable individual responses are or whether every participant changed in the same direction.
The standard deviation is the listed measure of dispersion. In general, it describes the spread of participant-level values around the mean. It is not the same as a confidence interval: the standard deviation describes variation among observations, while a confidence interval expresses uncertainty about an estimated quantity. No standard deviations or confidence intervals for the primary results are reported in the registry record.
Why distinguish the eye and assessment time?
The endpoint uses the worse eye, defined by the higher IOP at baseline, and measures change at Hour 0, Hour 2 and Hour 8 at Week 12. Naming the eye-selection rule makes clear which eye contributes to the primary endpoint. Naming the assessment times also matters because pressure measurements can be analyzed separately by time or through a model that accounts for their relationship. These are general possibilities, not a description of the analysis used in this trial. The statistical model and the handling of repeated measurements are not reported in the registry record.
In general, measurements from the same participant are related rather than independent. A method that accounts for this relationship can avoid treating repeated readings as if they came from unrelated people. The registry record does not report whether a repeated-measures model, separate comparisons, or another approach was used. It also does not report how baseline pressure entered the analysis beyond defining the worse eye and the change-from-baseline endpoint.
What does randomization contribute?
Random allocation is intended to reduce systematic differences between treatment groups at the start of a trial. It does not guarantee that all characteristics will be exactly balanced, especially in any one realized sample. In general, masking can reduce the influence of treatment expectations on participants, clinicians, or assessors, depending on who is masked. The record identifies the trial as randomized and double-masked but does not report the allocation sequence method, who was masked, or how masking was maintained.
The design is parallel-group: participants received their assigned formulation over the stated 12-week treatment period. A parallel design estimates outcomes in groups treated concurrently, subject to the prespecified analysis and the quality of follow-up. The specific protocol details needed to evaluate departures from assignment, adherence, and handling of treatment discontinuation are not reported in the registry record.
How should significance and uncertainty be read?
Statistical testing, in general, evaluates how compatible observed data are with a specified null hypothesis under a model. A p-value is not the probability that a treatment is effective, nor does it describe the magnitude or practical importance of an effect. Confidence intervals provide information about uncertainty and the range of effect sizes compatible with the data under a model. Neither p-values nor confidence intervals for the primary outcome are reported in the registry record. The analysis model, covariates, test sidedness, and significance threshold are also not reported.
Because the primary outcome has multiple assessment times, analysis choices can affect interpretation. A prespecified approach can clarify which comparisons are confirmatory and how results across times are handled. The record does not report whether an overall test, time-specific tests, or an adjustment for multiple comparisons was planned or used. No statistical analysis records are listed in the registry information described for this trial.
What do planning illustrations mean?
Sample-size planning estimates are hypothetical calculations about how many participants might be needed under stated assumptions. In general, such calculations depend on the effect to detect, variability, allocation, significance level, and statistical method. The planning description for this trial refers to a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of an observed effect. Any associated sample-size values are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The registry record does not report a trial-specific sample-size justification or the numerical planning estimates needed to evaluate those assumptions.
Observed power is not a substitute for reporting an effect estimate and its uncertainty. The primary outcome values and inferential results would be needed to understand what the data show. Those efficacy results are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when an analysis considers multiple outcomes, time points, groups, or statistical tests. In general, repeated testing can increase the chance of finding at least one apparently unusual result even when there is no underlying effect. Statistical plans sometimes address this through a hierarchy of outcomes, an overall test, or an adjustment to the criteria for interpreting multiple comparisons. The registry record does not report a multiplicity strategy.
The primary endpoint is assessed at Hour 0, Hour 2 and Hour 8 at Week 12, and secondary outcomes include change in worse-eye and average-eye IOP at each hour evaluated at Week 12. The record does not state which comparisons were prioritized for inference or how results across outcomes and times were treated. Since the primary results themselves are not reported in the registry record, the consequences of any multiplicity approach cannot be evaluated.
Missing outcome data can affect estimates if participants lack follow-up measurements. In general, appropriate interpretation depends on how much data are missing, why they are missing, and the assumptions and methods used to handle them. The registry record does not report missingness by group, imputation methods, sensitivity analyses, or details of participants’ follow-up.
The primary population is described as per protocol and excludes randomized participants with a protocol violation considered to have significantly affected conduct or results. The number analyzed and the criteria applied in practice are not reported in the registry record. The record also does not describe an intention-to-treat analysis or how participants who deviated from their assigned treatment were handled. These gaps limit assessment of selection and missing-data risks.
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/Timolol Formulation A | 4 | 278 | 1.4% |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 4 | 282 | 1.4% |
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/Timolol Formulation A | 59 of 278 |
| Bimatoprost/Timolol Fixed Combination Ophthalmic Solution | 55 of 282 |
Most frequent serious adverse event terms
| Event term | Organ system | Bimatoprost/Timolol Formulation A | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution |
|---|---|---|---|
| Intermittent claudication | Vascular disorders | 1 of 278 | 0 of 282 |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | 1 of 278 | 0 of 282 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 1 of 278 | 0 of 282 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 278 | 0 of 282 |
| Cerebellar infarction | Nervous system disorders | 0 of 278 | 1 of 282 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 278 | 1 of 282 |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 278 | 1 of 282 |
| Non-cardiac chest pain | General disorders | 0 of 278 | 1 of 282 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bimatoprost/Timolol Formulation A | Bimatoprost/Timolol Fixed Combination Ophthalmic Solution |
|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | 59 of 278 | 55 of 282 |
Serious events with the highest arm-level rate: intermittent claudication (0.4%), lumbar spinal stenosis (0.4%), osteoarthritis (0.4%), prostate cancer (0.4%), cerebellar infarction (0.4%).
The registry record lists serious adverse events for 4 participants at risk in the formulation A group and 4 participants at risk in the fixed-combination group. It lists other adverse events for 59 participants at risk in the formulation A group and 55 participants at risk in the fixed-combination group. These figures are participant counts, not measures of event severity beyond the separate serious-event classification.
The listed serious-event terms are intermittent claudication, lumbar spinal stenosis, osteoarthritis, prostate cancer, cerebellar infarction, and lung neoplasm malignant; each is reported as 0.4%. These terms describe events recorded in the registry and should not be interpreted from the record alone as caused by either study formulation. The record does not provide a causal assessment for the listed events.
Counts can describe what was recorded, but a comparison of safety requires attention to follow-up, event definitions, exposure, and uncertainty. The registry record does not report a statistical comparison of adverse events, detailed event timing, or the death counts. The listed counts therefore do not establish that one formulation had more or fewer adverse events in a statistically meaningful or causal sense.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-masked, parallel-group trial compared formulation A with a bimatoprost/timolol fixed combination in patients with glaucoma or ocular hypertension. It identifies the primary measure as change in worse-eye IOP at specified hours at Week 12 and defines the direction of change. These details clarify the question the study was designed to address.
The posted information does not include the primary outcome means, standard deviations, group contrast, confidence intervals, or p-values. It therefore does not establish the size or precision of any difference between formulations. The absence of these results in the registry record is not evidence that the treatments had identical results, and it is not evidence that one performed better. Neither conclusion can be drawn from the endpoint definition or adverse-event counts.
The safety information reports serious and other adverse-event participant counts, along with several serious-event terms. Counts are descriptive and do not by themselves determine whether an event was caused by treatment or whether the groups differ beyond chance. The registry record does not give death counts or a comparative safety analysis.
In general, a treatment estimate should be considered alongside its uncertainty, analysis population, missing-data handling, and the trial’s planned comparisons. Those details and the primary efficacy results are not reported in the registry record. The record supports describing the design and the outcomes it intended to assess, but it does not support a conclusion about relative efficacy or a definitive comparative safety judgment.
13. Why This Trial Matters Statistically
This trial is statistically notable for a common interpretation challenge: a clearly defined continuous endpoint can be present in a registry record without the numerical results needed to interpret it. The primary outcome identifies the measure, eye-selection rule, assessment times, and direction of change, but the registry record does not report the group means or their uncertainty. Without those estimates, the treatment comparison cannot be quantified.
The endpoint is assessed at several hours, and secondary IOP outcomes also cover worse-eye and average-eye measurements. Multiple related comparisons make a prespecified analysis strategy important. In general, readers need to know which comparisons are primary and how multiplicity is handled to distinguish confirmatory findings from exploratory ones. That strategy is not reported in the registry record.
The stated per-protocol population is another important interpretive feature. Such a population is defined by adherence to protocol criteria rather than simply by random assignment. In general, excluding participants after randomization can affect comparability if the exclusions relate to prognosis or outcomes. The registry record does not report participant flow, the number analyzed, or enough detail to assess the practical effect of the per-protocol rule.
Finally, safety counts should not be treated as a substitute for a comparative analysis. Serious and other adverse events are reported as counts, while the record does not provide inferential estimates or death counts. Taken together, the record illustrates why trial design, outcome definition, numerical estimates, uncertainty, and analysis details all contribute to 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 main limitation for interpreting efficacy is that the registry record does not report the primary outcome values or a statistical comparison. The endpoint is measured at Hour 0, Hour 2 and Hour 8, but no time-specific estimates or uncertainty measures are listed. It is therefore not possible to describe the observed magnitude, precision, or consistency of the primary outcome across assessment times.
The record does not report a detailed statistical analysis plan, model, covariate adjustment, multiplicity strategy, or trial-specific sample-size justification. The planning description refers to assumptions and illustrations, but no numerical illustration values are included in the registry record for this account. There is also no reported information about interim analyses.
The primary population is per protocol, but the number included and the reasons for exclusions are not reported in the registry record. Participant flow, missing outcome data, adherence, treatment discontinuation, and sensitivity analyses are also not described. These omissions prevent assessment of how exclusions or missingness may have affected the results.
For safety, the record provides participant counts and several serious-event terms, but does not report the death counts, event timing, causal assessments, or a comparative statistical analysis. The available counts should therefore be read descriptively. The registry record also does not report the concentration of formulation A, which limits description of that intervention’s formulation. These information gaps constrain interpretation; they do not establish that a particular bias or difference occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension — NCT01177098.
- Registry record last updated 2013-03-29; status last verified 2013-03.
- Results first posted 2013-03-12.
- 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
NCT01177098 is a completed Phase 3 randomized, double-masked, parallel-group trial sponsored by Allergan. It enrolled 561 patients with glaucoma or ocular hypertension. The record lists a start of 2010-10 and primary completion of 2012-02.
The trial compared bimatoprost/timolol formulation A with bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution. Both regimens were described as one drop in each eye every morning for 12 weeks. The primary endpoint was change from baseline in worse-eye IOP at Hour 0, Hour 2 and Hour 8 at Week 12, analyzed in a per-protocol population as described in the record.
Serious adverse events were reported for 4 participants in each group; other adverse events were reported for 59 in the formulation A group and 55 in the fixed-combination group. The registry record does not report the primary efficacy estimates, their uncertainty, or a comparative statistical analysis.