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 Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence (NCT01064882), a randomized phase 2 study. The primary outcome is Change From Baseline in Eyelash Length at Month 3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01064882 |
| Phase | Phase 2 |
| Condition | Eyelash Hypotrichosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 104 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
People with eyelash hypotrichosis who entered this randomized study. The registry lists enrollment of 104. The primary-outcome population was described as modified intent-to-treat: randomized subjects who started the study, received the intended medication, and completed at least one follow-up visit. The record does not give further demographic or clinical details for this population.
Intervention
Once-daily application of bimatoprost ophthalmic solution 0.005% or 0.015% to the upper eyelid margins. The study description focuses on increasing eyelash prominence and evaluating safety and efficacy.
Comparator
Bimatoprost ophthalmic solution 0.03%, also applied once daily to the upper eyelid margins. This is an active-dose comparison; the registry does not describe a placebo or untreated comparison group.
Primary question
How did eyelash length change from baseline to Month 3 in each treatment group? The primary measure was the mean change in length, in millimeters, with measurements from both eyes averaged for each subject. Positive changes indicated longer length and negative changes indicated shorter length. The registry record does not report the group results or a statistical comparison.
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel-group phase 2 trial of bimatoprost ophthalmic solution for eyelash hypotrichosis. The listed study arms received 0.005%, 0.015%, or 0.03% solution. The study description specifies once-daily application to the upper eyelid margins and identifies the 0.03% concentration as the comparator for the lower concentrations.
Random allocation is intended to make treatment groups comparable at the start of a study, on average. Masking is intended to reduce the influence of treatment knowledge on participants’ reports, clinical assessments, and study conduct. The registry labels masking as quadruple but does not identify which roles were masked or describe how masking was maintained. The parallel design means the arms represent separate treatment groups rather than a sequence of treatments received by each participant.
The record lists enrollment of 104 and status as completed. It gives a start date of 2010-03 and primary completion date of 2010-07. The primary endpoint was change from baseline in eyelash length at Month 3. Other listed outcomes address eyelash thickness and darkness, an overall prominence assessment, satisfaction, confidence, attractiveness, professionalism, and treatment satisfaction. Their presence indicates that the evaluation extended beyond the primary length measure; it does not establish what those outcomes showed.
The registry record does not report the allocation ratio, the randomization procedure, the setting, or detailed eligibility criteria. It also does not state the planned statistical model or explain how the study size was chosen. The record’s description of the trial design therefore establishes the broad comparison, but not all operational details needed to reproduce the study.
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 Ophthalmic Solution 0.005% | Bimatoprost Ophthalmic Solution 0.015% | Bimatoprost Ophthalmic Solution 0.03% |
|---|---|---|---|
| STARTED | 36 | 34 | 34 |
| COMPLETED | 34 | 32 | 32 |
| NOT COMPLETED | 2 | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)
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 Ophthalmic Solution 0.005% | Bimatoprost Ophthalmic Solution 0.015% | Bimatoprost Ophthalmic Solution 0.03% | Total |
|---|---|---|---|---|---|
| Participants analysed | 36 | 34 | 34 | 104 | |
| Age Continuous | years | 46.9 (32 to 55) | 45.4 (33 to 55) | 46.7 (31 to 55) | 46.3 (31 to 55) |
| Sex: Female, Male: Female | Participants | 36 | 34 | 34 | 104 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Eyelash Length at Month 3, measured over Baseline, Month 3.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | millimeters (mm) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in eyelash length at Month 3, measured in millimeters. The registry describes a mean measure and standard deviation. Measurements from both eyes were averaged for each subject before analysis. A positive change represented longer length than at baseline; a negative change represented shorter length.
Change from baseline is used to describe how a measured characteristic differs from its starting value over the study period. The mean summarizes the average change in a group, while the standard deviation describes how much individual changes vary around that mean. Neither summary by itself shows the precision of a group estimate or establishes whether groups differ; that requires inferential results, such as an estimated contrast and its uncertainty.
Eyelash length is a direct quantitative measure relevant to the study’s stated aim of increasing eyelash prominence. The registry also lists outcomes concerning other aspects of lashes and participant assessments, but the primary endpoint identifies the central measure specified for the study. The registry record does not provide group means, standard deviations, a treatment contrast, a confidence interval, or a p-value for this endpoint. Consequently, the endpoint’s definition can be described, but the magnitude and precision of any observed change cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the trial’s primary measure and analysis population, but it does not report the primary outcome values or inferential analyses. It is therefore not possible to describe the observed mean change in eyelash length for any arm, compare the arms, or assess the precision of a treatment contrast. The completed status and the presence of an endpoint definition do not substitute for outcome results.
The primary measure is a change from baseline at Month 3. The description clarifies how to interpret the direction of change: positive values correspond to longer lashes and negative values to shorter lashes. However, without the observed values, even the direction of the group-level changes is unknown from the registry record. No estimate should be inferred from the study title, the stated objective, or the concentrations used.
The registry lists secondary outcomes involving eyelash thickness and darkness, a clinical response on the Global Eyelash Assessment, satisfaction, the Confidence, Attractiveness, and Professionalism domain scores, and treatment satisfaction. The record does not provide results for those outcomes either. Their listing alone cannot establish whether assessments changed, how groups compared, or whether findings were consistent across measures.
The registry reports safety counts by treatment group. For serious adverse events, the recorded affected counts are 0 of 36 in the 0.005% group, 1 of 34 in the 0.015% group, and 0 of 34 in the 0.03% group. For other adverse events, the recorded counts are 0 of 36, 7 of 34, and 2 of 34, respectively. These are descriptive counts in the registry; the record does not provide a statistical comparison, event-level detail for all reported events, or exposure-adjusted rates. Deaths are not reported in the registry record.
Overall, the posted record supports a description of the trial’s design, endpoint definitions, analysis-population criteria, and listed safety counts. It does not support a conclusion about the size, direction, or statistical uncertainty of the primary treatment differences. The distinction matters: a study can be completed while its registry record still lacks the outcome estimates needed for an effectiveness interpretation.
9. Statistical Methods Explained
The registry describes a continuous primary outcome analyzed as a mean: change from baseline in eyelash length at Month 3. It also identifies standard deviation as the measure of dispersion. The record does not report the numerical endpoint results, a model, a test, or a confidence interval. The methods below explain the statistical ideas relevant to this outcome in general; they should not be read as a description of analyses confirmed in this trial.
What does a mean change describe?
For a continuous measurement, each participant can have a change score calculated by comparing the follow-up measurement with the baseline measurement. A group mean change summarizes the average of those individual changes. In this trial’s endpoint definition, a positive change means longer eyelash length and a negative change means shorter length. Averaging measurements from both eyes for each subject means the subject-level value, rather than each eye treated as an independent participant, is the stated basis for analysis.
A mean is useful because it gives a concise summary of the group’s average measured change. It can obscure variation, however. The standard deviation describes the spread of individual values around the group mean. A small standard deviation indicates that measurements are more closely clustered around the mean; a larger one indicates greater variation. Standard deviation is not the same as the uncertainty in the estimated mean or treatment contrast.
How should uncertainty be assessed?
In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis. For a treatment comparison, an interval around the estimated difference communicates both the direction and precision of the contrast. A relatively narrow interval indicates greater precision than a broad interval. Whether an interval includes a null value is sometimes used in inference, but interpretation should also consider the size and relevance of the estimate. The registry record does not report confidence intervals or treatment contrasts for the primary endpoint.
A p-value, when reported, describes how incompatible the observed data are with a specified null hypothesis under the statistical model. It does not measure the probability that the null hypothesis is true, nor does it quantify the size or importance of a difference. The registry record does not report p-values or identify the hypothesis tests used. No inferential conclusion can therefore be drawn from the endpoint description alone.
Why does the analysis population matter?
The registry defines the primary-outcome population as modified intent-to-treat: randomized subjects who started the study, were treated with the intended medication, and completed at least one follow-up visit. Such a definition clarifies who was eligible for the stated analysis, but it is not the same as an analysis of every randomized subject regardless of treatment received or follow-up. The record does not report how many subjects met the criteria in each arm or provide a participant flow account.
The record notes that one subject in the 0.015% group did not have baseline or Month 3 visit data for this outcome. This is relevant because a change score requires both a baseline and a follow-up measurement. The registry does not describe any imputation, other missing-data method, or sensitivity analysis. It is therefore not possible to determine how missing observations were handled or whether missingness could affect the estimates.
What can be said about planning assumptions?
General sample-size planning uses assumptions about the target effect, outcome variability, allocation, significance level, and desired power. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not a substitute for the trial’s observed estimate or uncertainty. The record does not provide numerical planning results or a trial-specific sample-size justification.
For count outcomes, over-dispersion is a general concern when variability exceeds what a simple model assumes. It can make standard errors too small if ignored. The primary endpoint is continuous, and the registry record does not identify a model for it; no claim can be made about whether over-dispersion or any particular alternative model was considered in the trial’s analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary endpoint and several secondary outcomes, but does not report a multiplicity strategy. When a study evaluates multiple outcomes or comparisons, the chance of at least one apparently notable result can increase if each is interpreted without regard to the full set of analyses. General approaches include designating a primary outcome, adjusting inference, or treating secondary findings as exploratory. The record does not say whether any such approach was prespecified or used. Because results are not reported, the relationship among findings across endpoints cannot be assessed.
The primary analysis population is described as modified intent-to-treat: randomized subjects who started the study, received the intended medication, and completed at least one follow-up visit. This definition gives some information about inclusion, but the record does not show how many participants were included in each arm or how exclusions were handled. It also does not report whether analyses using other populations were conducted.
For the primary outcome, the registry notes that one subject in the 0.015% group did not have baseline or Month 3 visit data. The record does not explain whether the missing measurements were excluded, imputed, or handled through another method. It does not describe the reasons for missingness or report sensitivity analyses. These omissions limit assessment of how missing data might influence the estimated changes.
The registry reports no analyses. It also does not report an interim-analysis plan, a statistical analysis plan, or details of prespecified hypothesis tests. The absence of those details in the registry record does not establish whether such procedures existed outside the record; it means they cannot be evaluated from the registry information.
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 Ophthalmic Solution 0.005% | 0 | 36 | 0.0% |
| Bimatoprost Ophthalmic Solution 0.015% | 1 | 34 | 2.9% |
| Bimatoprost Ophthalmic Solution 0.03% | 0 | 34 | 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 |
|---|---|
| Bimatoprost Ophthalmic Solution 0.005% | 0 of 36 |
| Bimatoprost Ophthalmic Solution 0.015% | 7 of 34 |
| Bimatoprost Ophthalmic Solution 0.03% | 2 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | Bimatoprost Ophthalmic Solution 0.005% | Bimatoprost Ophthalmic Solution 0.015% | Bimatoprost Ophthalmic Solution 0.03% |
|---|---|---|---|---|
| Appendicitis | Infections and infestations | 0 of 36 | 1 of 34 | 0 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bimatoprost Ophthalmic Solution 0.005% | Bimatoprost Ophthalmic Solution 0.015% | Bimatoprost Ophthalmic Solution 0.03% |
|---|---|---|---|---|
| Eyelids Pruritus | Eye disorders | 0 of 36 | 3 of 34 | 2 of 34 |
| Eyelid Pain | Eye disorders | 0 of 36 | 2 of 34 | 0 of 34 |
| Upper Respiratory Tract Infection | Infections and infestations | 0 of 36 | 2 of 34 | 0 of 34 |
Serious events with the highest arm-level rate: appendicitis (2.9%).
The registry reports serious adverse events by treatment group. The recorded number affected was 0 of 36 in the bimatoprost 0.005% group, 1 of 34 in the 0.015% group, and 0 of 34 in the 0.03% group. It identifies appendicitis at 2.9% among the top serious-event terms. The record does not provide enough detail to establish the full clinical course or attribution of that event.
For other adverse events, the recorded affected counts were 0 of 36, 7 of 34, and 2 of 34, respectively. These registry figures are descriptive. They do not, on their own, show that an event was caused by treatment or establish a statistically reliable difference between groups. The record does not provide exposure-adjusted rates, detailed event listings, or a comparative safety analysis.
Deaths are not reported in the registry record. That should not be interpreted as a confirmed count of zero. Safety counts also need to be read in light of the study population, follow-up, and reporting definitions; those details are not fully described in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, quadruple-masked, parallel-group phase 2 trial was conducted to compare three concentrations of bimatoprost ophthalmic solution for eyelash prominence. It describes change in eyelash length at Month 3 as the primary endpoint and lists additional measures of lash characteristics and participant assessments. It also gives adverse-event counts by treatment group.
What the record does not establish is the observed primary outcome result. Group means, standard deviations, treatment contrasts, confidence intervals, and p-values are not reported. Without those estimates, the direction and magnitude of change in each group and the precision of any between-group difference cannot be described. The registry’s statement of the study objective is not evidence that the objective was achieved.
The same caution applies to secondary outcomes. Their names indicate what was assessed, not what the results were. The posted record does not report results for those measures or explain how multiple outcomes were addressed. The safety counts are also descriptive and do not establish causation or comparative risk.
In general, a treatment comparison is most informative when estimates are accompanied by uncertainty and interpreted in light of the study design, outcome measurement, missing data, and analysis plan. Here, important results and methodological details are not reported in the registry record. The appropriate reading is therefore limited: the design, outcome definitions, analysis-population criteria, and listed safety counts can be described, but treatment effects cannot be inferred from this record.
This limitation does not mean that no analyses were performed outside the registry record, nor does it establish that there were no findings. It means the available registry information is insufficient to evaluate the primary efficacy comparison or its statistical precision. No medical conclusion about the treatment should be drawn from the endpoint description alone.
13. Why This Trial Matters Statistically
This trial illustrates why a registry entry’s design information and outcome results serve different purposes. Randomization, masking, and a parallel-group structure describe how the comparison was organized. The primary endpoint definition describes what was meant to be measured. Neither provides the observed treatment effect. Without outcome estimates and their uncertainty, even a clearly defined question cannot be answered statistically from the record.
The endpoint also highlights an important unit-of-analysis detail: measurements from both eyes were averaged for each subject. In general, measurements from the same person can be correlated, so treating each eye as an independent participant may give misleading precision. The stated averaging approach makes clear how the endpoint was defined at the subject level, although the record does not provide the analysis model or results.
The modified intent-to-treat description and the noted missing baseline or Month 3 data in the 0.015% group show why analysis populations and missing-data handling matter. Readers need to know who contributed to an estimate and what was done when required measurements were absent. The registry provides some information about eligibility for the primary analysis, but not the arm-level analysis counts or missing-data method.
Finally, the listed secondary outcomes and safety counts demonstrate that a trial can assess multiple dimensions while still leaving key interpretive information unavailable in a registry record. Statistical interpretation depends on effect estimates, precision, prespecification, and transparent reporting—not simply on a completed status or a list of outcomes. This record is useful for understanding the planned comparison, while the missing results limit what can be concluded about it.
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 for interpreting this trial from the registry record is the absence of reported primary-outcome results. No group-level changes, treatment contrasts, confidence intervals, or p-values are available. The listed endpoint therefore establishes what was intended to be measured, but not what was observed or how precise any comparison was.
The analysis description is also incomplete. The primary population is defined, and the record notes missing baseline or Month 3 data for one subject in the 0.015% group. It does not report the analysis sample sizes by arm, the method used for missing data, or sensitivity analyses. The statistical model and hypothesis-testing approach are not reported in the registry record.
Several secondary outcomes are listed, but their results and the approach to multiplicity are absent. This prevents assessment of the breadth and consistency of findings. The registry also does not provide detailed eligibility criteria, participant characteristics, allocation ratio, or the randomization and masking procedures. Such information would help assess applicability and potential sources of bias.
The safety record offers counts but limited context. It does not give exposure-adjusted rates, a full event listing, or detailed attribution information, and deaths are not reported in the registry record. Counts alone cannot establish causation or a comparative safety difference. These limitations are specific to what is recorded; they should not be taken as proof that corresponding analyses or details were absent from all study documentation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence — NCT01064882.
- Registry record last updated 2011-12-09; status last verified 2011-11.
- Results first posted 2011-12-09.
- 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 describes a completed randomized, quadruple-masked, parallel-group phase 2 study of bimatoprost ophthalmic solution 0.005%, 0.015%, and 0.03% for eyelash hypotrichosis. Enrollment was 104. The study evaluated once-daily application to the upper eyelid margins, with change from baseline in eyelash length at Month 3 as the primary endpoint.
The primary outcome was defined as mean change in millimeters, with both eyes averaged for each subject. The record describes a modified intent-to-treat population and notes missing baseline or Month 3 endpoint data for one subject in the 0.015% group. It lists secondary outcomes and adverse-event counts, but does not report primary or secondary efficacy results, inferential analyses, or the statistical analysis plan. Deaths are not reported in the registry record.