This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT02250651), a randomized phase 3 study. The primary outcome is Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02250651 |
| Phase | Phase 3 |
| Condition | Glaucoma, Open-Angle, Ocular Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 528 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Participants had open-angle glaucoma or ocular hypertension. The primary analysis population is described as participants in the ITT Population, defined in the record as all randomized participants, who had data available for analysis. The registry record does not report further details about participant characteristics in the primary result description.
Intervention
The study evaluated bimatoprost sustained-release (SR) at 15 μg and 10 μg. The arm descriptions state that the study-eye treatment was administered on Day 1, Week 16, and Week 32. Participants also received timolol vehicle, and sham administration was used in the non-study eye as described in the record.
Comparator
The active comparator was timolol 0.5%, administered in both eyes once in the morning and once in the evening for up to 20 months. Sham administration was described for both eyes at Day 1, Week 16, and Week 32. The registry record also lists timolol vehicle and a sham applicator without a needle among the interventions.
Primary question
The primary endpoint concerns change from baseline in intraocular pressure (IOP) in the study eye to Week 12, measured at Hours 0 and 2. The study eye was selected using the entry criteria and baseline IOP rules in the record. The comparison is intended to assess pressure change across treatment groups. Numerical estimates for the primary endpoint and a direct treatment comparison are not reported in the registry record.
3. Trial Design
This was a randomized, triple-masked, parallel-group phase 3 study. The registry lists an enrollment of 528 and identifies open-angle glaucoma and ocular hypertension as the conditions under study. Allergan is named as the sponsor. The study is marked completed.
The listed interventions include bimatoprost SR, a sham applicator without a needle, timolol 0.5% as an active comparator, and timolol vehicle. Arm descriptions identify bimatoprost SR doses of 15 μg and 10 μg, along with a timolol 0.5% comparator arm. In the bimatoprost arms, the described study-eye administrations occurred on Day 1, Week 16, and Week 32; the comparator description includes regular morning and evening timolol dosing. These descriptions also include sham procedures and vehicle dosing. The registry record does not report a complete randomization procedure or allocation ratio.
The brief study description states that treatment lasted 12 months and was followed by an 8-month extended follow-up. The comparator arm description specifies timolol dosing for up to 20 months. The record gives a study start date of 2014-12-15 and a primary completion date of 2018-10-25. It does not report further details about how masking was maintained or whether masking was assessed. The design labels identify the broad structure of the trial, but do not by themselves establish how every outcome was collected or analyzed.
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.
Treatment Period 1 (Day 1 to Week 15)
| Stage | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| STARTED | 176 | 176 | 176 |
| Received Sham or Bimatoprost SR | 176 | 175 | 173 |
| COMPLETED | 172 | 170 | 165 |
| NOT COMPLETED | 4 | 6 | 11 |
Reasons for not completing this period:
| Reason | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| Adverse Event | 0 | 2 | 2 |
| Lost to Follow-up | 1 | 0 | 0 |
| Personal Reasons | 2 | 3 | 5 |
| Protocol Deviation | 1 | 0 | 0 |
| Reason not Specified | 0 | 0 | 1 |
| Randomized but not Treated | 0 | 1 | 3 |
Treatment Period 2 (Week 16 to Week 31)
| Stage | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| STARTED | 165 | 168 | 165 |
| COMPLETED | 159 | 162 | 160 |
| NOT COMPLETED | 6 | 6 | 5 |
Reasons for not completing this period:
| Reason | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| Adverse Event | 4 | 1 | 0 |
| Lost to Follow-up | 0 | 0 | 3 |
| Personal Reasons | 2 | 3 | 2 |
| Protocol Deviation | 0 | 1 | 0 |
| Reason not Specified | 0 | 1 | 0 |
Treatment Period 3 (Week 32 to Week 52)
| Stage | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| STARTED | 147 | 156 | 159 |
| COMPLETED | 138 | 152 | 154 |
| NOT COMPLETED | 9 | 4 | 5 |
Reasons for not completing this period:
| Reason | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|
| Adverse Event | 4 | 1 | 1 |
| Lost to Follow-up | 1 | 2 | 1 |
| Personal Reasons | 2 | 0 | 2 |
| Reason not Specified | 2 | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Participants from the ITT Population, all randomized participants, with data available for analyses.
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.
Population: Intent-to-treat (ITT) Population included all randomized participants.
| Characteristic | Unit | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator | Total |
|---|---|---|---|---|---|
| Participants analysed | 176 | 176 | 176 | 528 | |
| Age, Continuous | years | 63.8 (SD 10.7) | 62.5 (SD 12.7) | 61.4 (SD 12.4) | 62.6 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 91 | 90 | 88 | 269 |
| Sex: Female, Male: Male | Participants | 85 | 86 | 88 | 259 |
| Race/Ethnicity, Customized: White | Participants | 116 | 115 | 104 | 335 |
| Race/Ethnicity, Customized: Black or African and American | Participants | 19 | 20 | 36 | 75 |
| Race/Ethnicity, Customized: Asian | Participants | 6 | 11 | 13 | 30 |
| Race/Ethnicity, Customized: Hispanic | Participants | 27 | 22 | 21 | 70 |
| Race/Ethnicity, Customized: Other | Participants | 8 | 8 | 2 | 18 |
| Intraocular Pressure (IOP): Hour 0 | millimeters of mercury (mmHg) | 24.39 (18.0 to 32.0) | 24.28 (15.0 to 32.0) | 24.46 (17.0 to 32.0) | 24.38 (15.0 to 32.0) |
| Intraocular Pressure (IOP): Hour 2 | millimeters of mercury (mmHg) | 23.41 (18.5 to 32.0) | 23.24 (14.0 to 32.0) | 23.43 (15.0 to 32.0) | 23.36 (14.0 to 32.0) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2), measured over Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2).
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | millimeters of mercury (mmHg) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in intraocular pressure (IOP) in the study eye to Week 12, assessed at Hours 0 and 2. IOP measures the fluid pressure inside the eye. The record defines the study eye as the eye meeting the entry criteria; if both eyes qualified, the eye with higher baseline IOP at Hour 0 was selected. If the Hour 0 values were equal, the right eye was designated as the study eye.
The outcome is continuous, and the reported parameter type is a least-squares mean. Change is measured in millimeters of mercury (mmHg). The record states that a negative change from baseline indicates improvement and a positive change indicates worsening. This endpoint expresses pressure change relative to each participant’s baseline rather than reporting only a pressure measurement at follow-up.
As a general statistical point, continuous outcomes can retain information about the size and direction of changes across participants. A model-based mean can also account for features specified in the analysis model. The registry record says a mixed-effects model with repeated measures was used, but does not provide the numerical endpoint estimates, standard errors, or treatment contrasts. The reason for selecting this endpoint beyond its stated role as the primary outcome is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a Week 12 IOP change endpoint and says it was analyzed using a mixed-effects model with repeated measures (MMRM). It does not report numerical least-squares mean changes, standard errors, confidence intervals, or a p-value for the primary endpoint. As a result, the size and precision of the estimated changes, and the evidence for differences between treatment groups, cannot be described from this record.
The endpoint has measurements at Hours 0 and 2. The posted analysis is not reduced to a single comparison because the primary outcome has several categories or time points. That matters for interpretation: a result at one measurement time should not be assumed to represent the result at another. The registry record does not specify a single primary contrast that would allow the multi-time-point outcome to be summarized as one treatment effect.
For the primary outcome, the record identifies a least-squares mean and standard error. As a general statistical point, a least-squares mean is an estimate derived from a statistical model, rather than necessarily the raw arithmetic average of observed values. A standard error describes the estimated uncertainty of a model-based estimate. It is not a measure of the spread of individual participant values. Without the posted estimates and their uncertainty, readers cannot determine how closely the data support any particular value or how much estimates may vary.
The record names the analysis population as participants from the ITT Population, which it defines as all randomized participants, with data available for analyses. This wording establishes the intended population label but does not explain how missing measurements were handled. The record also does not provide details of the model specification, such as its covariance structure or adjustment variables. Those omissions prevent a fuller assessment of how the estimates were constructed.
Safety information is reported separately as counts of participants affected by serious and other adverse events, along with deaths and selected serious-event terms. These are descriptive figures in the registry record. They should not be read as proof that an event was caused by a treatment, and the term percentages are not accompanied by an arm-specific breakdown in the information. Overall, the record permits a description of design, endpoint, and selected safety counts, but not a numerical conclusion about the primary efficacy comparison.
9. Statistical Methods Explained
The primary endpoint is analyzed with a mixed-effects model with repeated measures (MMRM), according to the registry record. The outcome is continuous, and the analysis reports least-squares means with standard errors. The record does not describe additional model details, including the covariance structure, model terms, or any adjustments beyond what can be inferred from the method name. Those elements are not reported in the registry record.
What does a repeated-measures model do?
As a general statistical explanation, repeated-measures methods are designed for data in which outcomes are collected more than once for the same participant. Measurements from one participant are often related to each other, so treating them as independent observations can give an inaccurate account of uncertainty. A mixed-effects model can represent this within-participant structure while estimating average patterns across participants. The registry record identifies measurement times at Hours 0 and 2 for the primary outcome and specifies the Week 12 assessment. It does not state the exact model structure used to account for relationships among those observations.
MMRM can use available outcome measurements under assumptions about the data and the model. As a general statistical point, the method does not, by its name alone, reveal whether missing data are frequent, why they are missing, or whether the assumptions are appropriate. The record does not describe missing-data patterns, sensitivity analyses, or a specific missing-data assumption. Consequently, the method label should not be treated as a full account of how incomplete measurements were addressed.
What do least-squares means and standard errors represent?
As a general statistical explanation, a least-squares mean is a model-based estimate of an average. Depending on the model, it may differ from the unadjusted average calculated directly from observed values. A standard error describes the uncertainty in an estimated mean. It does not describe the range of participant outcomes, and it should not be interpreted as an individual-level variability measure. The registry record identifies the standard error as the dispersion measure for the primary outcome, but the numerical estimates and standard errors are not reported in the registry record.
A confidence interval is, in general, a range of values constructed to represent uncertainty around an estimate under a specified statistical procedure. The width of an interval reflects both the variability in the data and the amount of information available. The primary endpoint confidence intervals are not reported in the registry record, so the precision of the treatment estimates cannot be assessed from intervals. A p-value, when reported, addresses compatibility between data and a specified null hypothesis under the analysis assumptions; it does not describe effect size or clinical importance. A primary endpoint p-value is not reported in the registry record.
Why can over-dispersion matter?
As a general statistical point, over-dispersion occurs when observed variability is greater than a model’s assumptions allow. If a model underestimates variability, standard errors may be too small and uncertainty may appear narrower than it should. This concept is particularly relevant to some count-data models. The primary outcome in this trial is continuous IOP change, and the record does not report an over-dispersion assessment or describe a count-data model. Over-dispersion should therefore not be assumed to have been an issue in this analysis.
The registry record reports sample-size planning assumptions for illustrative calculations based on the observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These assumptions describe planning illustrations, not the trial’s own sample-size justification or observed power. No numerical illustration outputs are reported in the registry record. The record does not report the trial’s original sample-size justification.
For non-time-to-event outcomes, the stated sample-size convention is participants per arm; time-to-event calculations use total events. These conventions explain how planning quantities are expressed, not what was observed in this trial. Sample-size calculations based on an observed effect are conditional on that effect estimate and the stated assumptions. They do not establish the probability that the trial detected an effect or replace interpretation of the actual estimates and their uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes measurements at Hours 0 and 2 at Week 12. The registry record indicates that the primary outcome has several categories or time points and is not reduced to one comparison. It also lists 8 outcome measures and 24 analyses. The record does not explain how those multiple outcomes, times, or analyses were handled for statistical testing.
As a general statistical point, testing multiple hypotheses can increase the chance of obtaining at least one apparently unusual result even when there is no underlying treatment difference. Prespecified testing hierarchies or multiplicity adjustments can address that concern, but the choice and implementation depend on the trial’s analysis plan. The registry record does not report a multiplicity adjustment, a hierarchy of hypotheses, or whether the primary endpoint results were treated as separate tests. It is therefore not possible to characterize the family-wise error control from the available information.
The primary analysis population is described as participants from the ITT Population—all randomized participants—with data available for analyses. This wording does not mean that all randomized participants necessarily contributed a Week 12 measurement. The registry record does not report the number with endpoint data at each time, reasons for missing observations, methods for handling missing data, or sensitivity analyses. It also does not report whether any interim analyses were conducted. Missing-data assumptions and interim monitoring plans are not reported in the registry record.
As a general statistical point, missing-data methods can affect estimates when outcome availability is related to participant characteristics or outcomes. A named repeated-measures model does not, by itself, establish how this possibility was assessed. Without the missingness information and analysis details, readers cannot evaluate the robustness of the primary estimates to incomplete follow-up.
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 SR 15 μg | 36 | 176 | 20.5% |
| Bimatoprost SR 10 μg | 22 | 175 | 12.6% |
| Timolol 0.5%: Comparator | 16 | 173 | 9.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bimatoprost SR 15 μg | 1 of 176 |
| Bimatoprost SR 10 μg | 0 of 176 |
| Timolol 0.5%: Comparator | 1 of 176 |
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 SR 15 μg | 133 of 176 |
| Bimatoprost SR 10 μg | 103 of 175 |
| Timolol 0.5%: Comparator | 72 of 173 |
Most frequent serious adverse event terms
| Event term | Organ system | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|---|
| Corneal endothelial cell loss | Eye disorders | 9 of 176 | 3 of 175 | 0 of 173 |
| Pneumonia | Infections and infestations | 3 of 176 | 0 of 175 | 0 of 173 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 3 of 176 | 0 of 175 | 0 of 173 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 85 | 0 of 85 | 1 of 88 |
| Corneal oedema | Eye disorders | 2 of 176 | 1 of 175 | 0 of 173 |
| Atrial fibrillation | Cardiac disorders | 1 of 176 | 1 of 175 | 0 of 173 |
| Myocardial infarction | Cardiac disorders | 1 of 176 | 0 of 175 | 1 of 173 |
| Vomiting | Gastrointestinal disorders | 0 of 176 | 0 of 175 | 2 of 173 |
| Fall | Injury, poisoning and procedural complications | 0 of 176 | 2 of 175 | 0 of 173 |
| Hip fracture | Injury, poisoning and procedural complications | 0 of 176 | 1 of 175 | 1 of 173 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bimatoprost SR 15 μg | Bimatoprost SR 10 μg | Timolol 0.5%: Comparator |
|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | 73 of 176 | 48 of 175 | 20 of 173 |
| Corneal endothelial cell loss | Eye disorders | 38 of 176 | 12 of 175 | 2 of 173 |
| Conjunctival haemorrhage | Eye disorders | 17 of 176 | 20 of 175 | 15 of 173 |
| Eye pain | Eye disorders | 23 of 176 | 12 of 175 | 9 of 173 |
| Foreign body sensation in eyes | Eye disorders | 19 of 176 | 18 of 175 | 2 of 173 |
| Intraocular pressure increased | Investigations | 17 of 176 | 15 of 175 | 6 of 173 |
| Dry eye | Eye disorders | 18 of 176 | 12 of 175 | 7 of 173 |
| Nasopharyngitis | Infections and infestations | 9 of 176 | 12 of 175 | 14 of 173 |
| Punctate keratitis | Eye disorders | 14 of 176 | 10 of 175 | 8 of 173 |
| Eye irritation | Eye disorders | 13 of 176 | 10 of 175 | 9 of 173 |
Serious events with the highest arm-level rate: corneal endothelial cell loss (5.1%), prostate cancer (2.4%), pneumonia (1.7%), osteoarthritis (1.7%), vomiting (1.2%).
The registry record lists participants at risk and participants affected by serious and other adverse events in each group. In the Bimatoprost SR 15 μg group, 176 participants were at risk for both categories; 36 were affected by serious adverse events and 133 by other adverse events. One death is listed. In the Bimatoprost SR 10 μg group, 175 participants were at risk; 22 were affected by serious adverse events and 103 by other adverse events, with 0 deaths listed. In the Timolol 0.5% comparator group, 173 participants were at risk; 16 were affected by serious adverse events and 72 by other adverse events, with 1 death listed.
The record lists corneal endothelial cell loss at 5.1%, prostate cancer at 2.4%, pneumonia at 1.7%, osteoarthritis at 1.7%, vomiting at 1.2%, and fall at 1.1% among the top serious-event terms. It does not report an arm-specific breakdown for these terms in the information available.
These figures describe reported counts and terms, not treatment causation. The registry record does not provide event timing, exposure-adjusted rates, or a statistical comparison of safety outcomes. A count of affected participants is distinct from a count of all event episodes, and the record does not provide enough detail to infer recurrence or severity beyond the serious-event classification.
12. What the Result Does, and Does Not, Mean
The record establishes that this was a randomized, triple-masked, parallel-group phase 3 trial with bimatoprost SR and timolol 0.5% treatment arms. It specifies a primary endpoint based on change in study-eye IOP to Week 12 at Hours 0 and 2, and names MMRM as the analysis method. It also reports selected adverse-event counts and deaths by group. These details describe the study’s design and what was measured, but they do not supply the numerical primary endpoint results.
Because least-squares mean changes, standard errors, treatment contrasts, confidence intervals, and primary endpoint p-values are not reported in the registry record, the magnitude, direction, and precision of the primary treatment differences cannot be evaluated from this information. The endpoint description explains how negative and positive changes are interpreted, but does not establish the observed direction of change in any group. It would not be appropriate to infer an efficacy conclusion from the study title, design, or endpoint definition alone.
The safety counts indicate how many participants were classified as affected in each listed category, and the record identifies selected serious-event terms. They do not establish that a treatment caused an event or that one group had greater risk. Such interpretation would require fuller information about event definitions, timing, exposure, follow-up, and comparative analyses, which is not reported in the registry record.
As a general statistical point, an estimate and its uncertainty are both important when judging evidence. A small or large estimated difference can have different interpretations depending on its precision and the outcome’s context. Here, the primary estimates and uncertainty are absent, so neither the size of a difference nor the strength of evidence about a difference can be described. This record supports a careful account of the trial framework, not a conclusion about treatment benefit or lack of benefit.
13. Why This Trial Matters Statistically
This trial illustrates why a registry entry needs to be read at more than one level. The design labels establish randomization, masking, and a parallel-group structure, while the endpoint description identifies the measure, eye-selection rule, measurement times, direction of change, and analysis method. Together, those details help define what the primary question concerns. They do not substitute for the numerical estimates needed to interpret a treatment comparison.
The endpoint is repeated over measurement times, and the registry record identifies a model that can account for repeated observations. That makes the distinction between an overall model-based mean, a time-specific estimate, and a direct contrast important. Since the record does not reduce the primary outcome to one comparison or report the underlying numerical results, readers should avoid treating the endpoint title as evidence of a particular result.
The entry also demonstrates the limits of interpreting safety counts in isolation. Counts of affected participants and deaths provide descriptive information, but they do not establish causality or comparative risk. The listed serious-event terms add detail, yet the record does not supply an arm-specific term breakdown or comparative safety analysis.
Finally, the analysis population wording, missing-data details, and multiplicity information matter for assessing how robust results would be. The record names the ITT population and MMRM but does not provide the underlying estimates or fuller analytical specifications. Statistically, the clearest lesson is that a well-defined design and endpoint are necessary for interpretation, but they are not enough to determine what the trial’s primary comparison showed.
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 consequential limitation for interpreting the primary outcome is that numerical results are not reported in the registry record. The entry identifies least-squares means and standard errors as the reporting approach, but does not give the estimates, treatment contrasts, confidence intervals, or p-values. Therefore, the magnitude, direction, and precision of any primary treatment difference cannot be assessed.
The endpoint involves more than one measurement time, and the record states that it is not reduced to one comparison. It does not identify a single contrast for interpretation or explain how the measurements at Hours 0 and 2 relate to any primary testing strategy. Although an MMRM is named, details of model specification and assumptions are not reported in the registry record.
The analysis population is described as all randomized participants with data available for analysis. The record does not state how many participants contributed data at each endpoint time, how missing measurements were handled, or whether sensitivity analyses were performed. The multiplicity strategy and any interim analyses are also not reported in the registry record. These gaps limit assessment of the analysis plan and the robustness of any findings.
Safety information is presented as affected-participant counts, deaths, and selected serious-event terms. The record does not provide timing, exposure-adjusted summaries, or arm-specific counts for the listed terms. As a result, these figures should be understood descriptively rather than as comparative or causal evidence. The arm descriptions also do not establish every operational detail of treatment delivery, masking, or adherence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension — NCT02250651.
- Registry record last updated 2021-07-28; status last verified 2021-06.
- Results first posted 2021-07-28.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry identifies NCT02250651 as a completed, randomized, triple-masked, parallel-group phase 3 study sponsored by Allergan. It enrolled 528 participants with open-angle glaucoma or ocular hypertension. The study evaluated bimatoprost SR at 15 μg and 10 μg against timolol 0.5%.
The primary outcome was change from baseline in study-eye IOP to Week 12 at Hours 0 and 2, analyzed using a mixed-effects model with repeated measures. The record describes least-squares means and standard errors but does not report the numerical primary outcome estimates or treatment comparison.
It lists serious and other adverse-event counts and deaths by group, as well as selected serious-event terms. The study description states a 12-month treatment period and an 8-month extended follow-up. Details of the multiplicity strategy, missing-data handling, interim analyses, and the original sample-size justification are not reported in the registry record.