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 Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension (NCT02105285), a randomized phase 3 study. The primary outcome is Decrease From Baseline in Intraocular Pressure at Week 8 Predose.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02105285 |
| Phase | Phase 3 |
| Condition | Glaucoma, Ocular Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 193 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects with glaucoma or ocular hypertension who were insufficiently responsive to carteolol long-acting ophthalmic solution. The registry record reports enrollment of 193. Further eligibility criteria and details about the population included in the primary analysis are not reported in the registry record.
Intervention
OPC-1085EL ophthalmic solution, administered once daily.
Comparator
Carteolol long-acting ophthalmic solution, administered once daily. The primary and secondary outcome description specifies comparison of OPC-1085EL with carteolol, rather than with the carteolol and latanoprost combination group.
Primary question
At Week 8 predose, what was the mean decrease from baseline in intraocular pressure in each group? The posted primary results report a mean decrease of 3.5 mmHg for OPC-1085EL and 1.6 mmHg for carteolol, with a 95% confidence interval for each group mean. The registry record does not report a formal between-group estimate or test for this primary outcome.
The clinical question is framed around a population described as insufficiently responsive to carteolol long-acting ophthalmic solution. That context matters when interpreting the comparison: the posted outcomes describe this enrolled population and the specified study treatments, not all people with glaucoma or ocular hypertension. Both study treatments were described as once daily. The registry record also lists a carteolol and latanoprost ophthalmic solution group in the safety results, but the primary-outcome description says the OPC-1085EL group was compared only with the carteolol group for the primary and secondary outcome analyses. The registry record does not report further details about the role of the combination group in the study design or analysis beyond that description.
3. Trial Design
The registry identifies this as a phase 3, randomized, quadruple-masked, parallel study. Its status is completed. Enrollment is reported as 193, and the study concerns glaucoma or ocular hypertension. The study start is recorded as 2014-04 and primary completion as 2015-01. The trial’s stated purpose was to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution among subjects insufficiently responsive to carteolol long-acting ophthalmic solution.
The two named treatment arms in the primary results are OPC-1085EL ophthalmic solution and carteolol long-acting ophthalmic solution; both are described as once daily. For the primary outcome, the posted arm-level results include 78 participants in the OPC-1085EL group and 77 in the carteolol group. Those arm-specific counts describe the primary outcome results and should not be treated as a complete account of enrollment or of every analysis population. The registry record also reports a carteolol and latanoprost ophthalmic solution group in the adverse-event data. The primary-outcome description explicitly distinguishes that combination group from the primary comparison.
Randomization and masking describe important design features, but the registry record does not report how the random sequence was generated, how allocation was concealed, or which roles were masked. The record identifies the study as quadruple masked without further detail about the masked parties. It does not report the planned sample-size justification, the statistical analysis plan, interim analyses, or detailed eligibility criteria. The parallel model indicates that the trial was organized around groups receiving their assigned treatment rather than a stated crossover comparison; further scheduling and follow-up details are not reported in the registry 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.
Overall Study
| Stage | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|
| STARTED | 78 | 78 | 37 |
| COMPLETED | 76 | 76 | 37 |
| NOT COMPLETED | 2 | 2 | 0 |
Reasons for not completing this period:
| Reason | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|
| Adverse Event | 1 | 1 | 0 |
| Protocol Violation | 0 | 1 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 |
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 | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|---|---|
| Participants analysed | 78 | 78 | 37 | 193 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 49 | 42 | 24 | 115 |
| Age, Categorical: >=65 years | Participants | 29 | 36 | 13 | 78 |
| Age, Continuous | years | 57.9 (SD 12.1) | 60.6 (SD 10.6) | 56.6 (SD 12.6) | 58.8 (SD 11.7) |
| Sex: Female, Male: Female | Participants | 40 | 39 | 21 | 100 |
| Sex: Female, Male: Male | Participants | 38 | 39 | 16 | 93 |
| Region of Enrollment: Japan | participants | 78 | 78 | 37 | 193 |
6. Primary Endpoint
The registry lists the primary outcome as Decrease From Baseline in Intraocular Pressure at Week 8 Predose, measured over Baseline, Week 8 Predose.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean decrease from baseline in intraocular pressure at Week 8 predose, measured in mmHg. It is a continuous outcome: each participant’s measurement can take values across a scale, and the group result is expressed as a mean. The timeframe is baseline to Week 8 predose. A decrease from baseline expresses the change in pressure during that interval, with the reported positive values representing the magnitude of the decrease.
Intraocular pressure is the clinical measure selected for the trial’s stated efficacy question. A predose measurement captures pressure at a specified time relative to study-drug administration, rather than at the post-administration time points listed among the secondary outcomes. That timing gives the primary endpoint a clearly defined measurement context. The registry record reports a mean decrease of 3.5 mmHg for OPC-1085EL, with a 95% confidence interval of 3.1 to 3.9, and a mean decrease of 1.6 mmHg for carteolol, with a 95% confidence interval of 1.2 to 2.0.
These are estimates for each group separately. A difference between group means would directly summarize the contrast between treatments, but a primary between-group estimate and its confidence interval are not reported in the registry record. Therefore, the arm-level results describe the observed changes but do not, on their own, provide the precision of a formal comparative estimate or establish how the trial’s planned analysis handled the comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results show a mean decrease in intraocular pressure from baseline to Week 8 predose of 3.5 mmHg in the OPC-1085EL group and 1.6 mmHg in the carteolol group. The reported 95% confidence intervals are 3.1 to 3.9 and 1.2 to 2.0, respectively. These intervals convey uncertainty around each group’s estimated mean decrease. They are not confidence intervals for the difference between groups.
The arm-level estimates place the OPC-1085EL mean decrease higher than the carteolol mean decrease. However, the registry record does not report a primary between-group estimate, confidence interval for that contrast, or formal primary-outcome test. The outcome description refers to comparing groups, but the posted primary values are group summaries. Without a reported comparative estimate and its analysis details, the registry record does not show the magnitude and precision of the primary treatment contrast as analyzed by the sponsor. The overlap or separation of group-specific confidence intervals is not a substitute for a confidence interval or test for the between-group difference.
Some secondary endpoint records include recalculated, unadjusted comparisons derived from the posted summary statistics. Those comparisons give a way to describe the secondary arm-level means relative to one another, but they do not replace the sponsor’s planned analysis. Their p-values are unadjusted and should not be interpreted as accounting for the number of outcomes examined. The registry record lists no reported analyses for those secondary endpoints. Their calculated results therefore need to be distinguished from sponsor-reported inferential results.
The secondary measurements follow a consistent direction in the numerical summaries: the reported OPC-1085EL group means are lower than the carteolol means at predose and at the listed post-administration time points. For the outcomes expressed as a decrease from baseline, the direction of interpretation depends on the outcome’s definition. This broad consistency can be considered alongside the primary arm-level pattern, but it does not resolve the absence of a reported primary contrast or establish that all outcomes were prespecified for confirmatory testing.
The registry record reports 193 enrolled, while the primary outcome arm summaries list 78 and 77 participants. The record does not explain the relation between enrollment and the outcome-specific analysis counts, or whether missing outcome measurements affected those counts. The numerical summaries also do not explain whether the analysis adjusted for baseline pressure or other variables. Those details, along with analysis-population definitions and missing-data methods, are not reported in the registry record.
9. Statistical Methods Explained
What does a group mean describe?
For a continuous measure such as intraocular pressure, the mean is an average across participants with an outcome measurement in the group. It condenses the group’s observed values into a single estimate. A mean does not describe the full distribution: participants may have measurements spread around it, and the mean alone does not show the range of individual responses. The primary result is a mean change from baseline, while the secondary results include mean pressure at specified Week 8 measurement times. These are related but distinct summaries.
How should the confidence intervals be read?
A confidence interval describes the statistical uncertainty around an estimated quantity under the method used to construct it. For the primary outcome, the intervals accompany each arm’s mean decrease. The reported intervals are 3.1 to 3.9 mmHg for OPC-1085EL and 1.2 to 2.0 mmHg for carteolol. They concern the group means, not the difference between treatment groups. A direct treatment comparison requires its own estimated contrast and uncertainty interval. The registry record does not report that primary contrast.
What do standard errors convey?
The secondary outcome summaries report standard errors alongside group means. A standard error describes the estimated precision of a mean, rather than the spread of individual participant measurements. It is affected by both the variability in the observations and the amount of information contributing to the estimate. It should not be read as if it were a standard deviation. The registry record’s secondary means and standard errors are posted arm-level summaries; detailed methods for producing them are not reported in the registry record.
What are the recalculated comparisons?
For the posted secondary summaries, unadjusted mean differences and confidence intervals have been recalculated from the arm-level statistics. These are simple comparisons of the reported group means and are not identified as sponsor-reported analyses. For example, the recalculated predose comparison is a mean difference of 1.9 mmHg, with a confidence interval from 1.346 to 2.454, and the unadjusted p-value is <0.001. At the post-administration time points, the recalculated mean differences are 2.1 mmHg and 2.7 mmHg, and each has an unadjusted p-value of <0.001. These figures describe the recalculations, not a complete account of the trial’s prespecified analysis.
A p-value assesses how compatible the data are with a specified null model under the test assumptions. It is not the probability that the null hypothesis is true, nor does it measure clinical importance. An unadjusted p-value does not account for testing multiple outcomes. The registry record does not report a sponsor analysis for these secondary results, and it does not report the planned multiplicity strategy.
Why do planning illustrations differ from observed trial results?
Sample-size planning illustrations use assumptions about a target effect, variability, significance level, allocation, and statistical model to estimate how many participants per arm would be needed under those assumptions. The posted illustrations are based on fractions of the observed secondary effects, assume equal allocation between the two arms, use a two-sided significance level of 0.05, and use a normal approximation. They are retrospective planning illustrations, not the trial’s design justification and not observed power. They do not establish the probability that this completed trial detected an effect. The trial’s own sample-size assumptions and justification are not reported in the registry record.
Why can over-dispersion matter?
As a general statistical point, over-dispersion means that observed variability is greater than a model assumes. If a model understates variability, standard errors can be too small and confidence intervals too narrow, making results appear more precise than they are. This is relevant when a model’s variance assumptions are important to inference. The reported primary outcome is continuous, and the registry record does not identify a count model or report evidence of over-dispersion. The point is general rather than a description of a method used in this trial.
The registry record does not report the sponsor’s detailed methods for the primary comparison, adjustments for baseline or other covariates, assumptions used to handle missing observations, or analysis populations. The recalculated secondary comparisons should therefore be read as transparent, unadjusted summaries of posted statistics rather than as substitutes for those unreported methods.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when a study examines several outcomes, time points, or comparisons. The registry record lists a primary outcome and five secondary outcome titles, and it reports detailed numerical results for some secondary measures. Repeated testing can increase the chance of at least one apparently notable result even when no true differences exist. A prespecified plan can address this by defining a primary comparison, controlling error across tests, or distinguishing confirmatory outcomes from exploratory ones. The registry record does not report such a plan, so the recalculated secondary p-values should be treated as unadjusted rather than as evidence that accounts for all testing.
The registry record reports no sponsor-reported analyses for the detailed secondary outcomes. It also does not report the sponsor’s analysis method for the primary comparison, the analysis populations, or whether any adjustment was made for baseline characteristics. Those details are important for understanding how estimates and tests were generated and which participants contributed to each analysis.
Missing-data handling is another unresolved issue. The registry provides outcome-specific arm counts for several results, but it does not describe why counts differ across outcomes or how missing measurements were handled. It does not report whether the analysis used all randomized participants, only participants with observed measurements, or another defined population. Nor does it report imputation methods, sensitivity analyses, or assumptions about missingness. These methods can affect the interpretation of estimates if outcome availability is related to participant characteristics or outcomes.
The record does not report interim analyses or any planned stopping rules. These omissions should be read as gaps in the registry record, not evidence that a particular procedure was or was not used. Without the protocol or statistical analysis plan, the prespecified hierarchy of outcomes, handling of missing data, and intended multiplicity control cannot be established from the registry information alone.
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 |
|---|---|---|---|
| OPC-1085EL Ophthalmic Solution | 0 | 78 | 0.0% |
| Carteolol Long-acting Ophthalmic Solution | 1 | 78 | 1.3% |
| Carteolol and Latanoprost Ophthalmic Solution | 0 | 37 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| OPC-1085EL Ophthalmic Solution | 21 of 78 |
| Carteolol Long-acting Ophthalmic Solution | 3 of 78 |
| Carteolol and Latanoprost Ophthalmic Solution | 4 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|---|
| Subdural haematoma | Injury, poisoning and procedural complications | 0 of 78 | 1 of 78 | 0 of 37 |
Most frequent non-serious adverse event terms
| Event term | Organ system | OPC-1085EL Ophthalmic Solution | Carteolol Long-acting Ophthalmic Solution | Carteolol and Latanoprost Ophthalmic Solution |
|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | 2 of 78 | 1 of 78 | 2 of 37 |
| Nasopharyngitis | Infections and infestations | 2 of 78 | 2 of 78 | 0 of 37 |
| Eye irritation | Eye disorders | 2 of 78 | 0 of 78 | 1 of 37 |
| Eye pain | Eye disorders | 3 of 78 | 0 of 78 | 0 of 37 |
| Ocular hyperaemia | Eye disorders | 2 of 78 | 0 of 78 | 1 of 37 |
| Abnormal sensation in eye | Eye disorders | 2 of 78 | 0 of 78 | 0 of 37 |
| Blepharitis | Eye disorders | 2 of 78 | 0 of 78 | 0 of 37 |
| Punctate keratitis | Eye disorders | 2 of 78 | 0 of 78 | 0 of 37 |
| Foreign body sensation in eyes | Eye disorders | 2 of 78 | 0 of 78 | 0 of 37 |
| Eye pruritus | Eye disorders | 2 of 78 | 0 of 78 | 0 of 37 |
Serious events with the highest arm-level rate: subdural haematoma (1.3%).
The adverse-event record lists serious adverse events for three groups. It reports 0 serious adverse events among 78 participants in the OPC-1085EL group, 1 among 78 in the carteolol group, and 0 among 37 in the carteolol and latanoprost group. The record also identifies subdural haematoma at 1.3% among the top serious-event terms. It does not specify in that term listing which group the event belongs to, so the term should not be assigned to a group based on these entries alone.
Serious adverse-event counts are descriptive and should be interpreted in light of the group sizes and the information available in the registry. The record does not report death counts; those data are not reported in the registry record. It separately lists other adverse events affecting 21 participants in the OPC-1085EL group, 3 in the carteolol group, and 4 in the carteolol and latanoprost group. These other-event counts are not the same measure as serious adverse events. The registry entries do not provide enough detail to assess event timing, relatedness to treatment, or comparative risk with a formal statistical analysis.
12. What the Result Does, and Does Not, Mean
The posted primary results describe the average change in intraocular pressure from baseline to Week 8 predose in each treatment group. The mean decrease is 3.5 mmHg for OPC-1085EL and 1.6 mmHg for carteolol, with group-specific 95% confidence intervals. The numbers show the direction and precision of each reported group mean. They do not provide a directly reported estimate of the treatment-group contrast.
These results do not by themselves establish the size or precision of a primary between-group effect under the sponsor’s analysis. The registry record does not report a formal primary comparison, a primary p-value, or a confidence interval for the difference. The group-specific intervals should not be substituted for those missing comparative statistics. No conclusion about clinical importance can be drawn from the means alone because a threshold for a clinically meaningful difference is not reported in the registry record.
The findings also have a defined scope. The study concerns subjects with glaucoma or ocular hypertension who were insufficiently responsive to carteolol long-acting ophthalmic solution, and it evaluates the specified once-daily treatments. The registry results do not establish what would happen in populations with different eligibility characteristics, under different treatment schedules, or over follow-up periods not reported in the record. The primary measurement is at Week 8 predose; the registry does not report longer-term primary outcome results.
The secondary summaries add descriptive context, but their recalculated comparisons are unadjusted and are not reported sponsor analyses. Without a reported multiplicity plan and analysis methods, they should not be treated as definitive additional proof. Likewise, adverse-event counts are descriptive and do not alone establish comparative safety. The record provides useful outcome summaries, but important details about analysis populations, missing data, and prespecified methods are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why arm-level results and treatment contrasts should be distinguished. A group mean and its confidence interval describe an outcome within that group. The central comparative question, however, concerns the difference between groups. For the primary endpoint, the registry reports each mean decrease and its interval but does not report the contrast and its uncertainty. Readers can recognize the observed pattern without mistaking the separate group summaries for a complete comparative analysis.
The outcome timing also matters statistically. The primary measure is a change from baseline at Week 8 predose, while secondary measures include absolute pressure at predose and at specified post-administration times. These different definitions answer related but nonidentical questions. An endpoint should be interpreted according to its measurement scale and timing rather than grouped with other measures simply because they concern intraocular pressure.
The record further demonstrates the importance of distinguishing sponsor-reported analyses from recalculations based on posted summaries. The secondary contrasts and p-values are unadjusted recalculations; they are not identified as sponsor-reported analyses. Their interpretation depends on assumptions and does not account for the collection of outcomes. Planning illustrations based on observed effects also do not recover the original design rationale or measure the trial’s observed power.
Finally, enrollment, outcome-specific counts, and safety groups are not interchangeable. The record reports 193 enrolled, primary endpoint counts of 78 and 77 in the two named arms, and an additional group in the safety data. Without further information about analysis populations and missing measurements, those figures should remain tied to their stated contexts. This is a useful example of how registry results can support careful descriptive reading while leaving key inferential questions unresolved.
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.
A central limitation of the posted primary results is that they report arm-specific means and confidence intervals but not the primary between-group estimate, confidence interval, or test. This limits how directly the treatment contrast can be quantified from the registry record. The absence of those statistics does not show that the study sponsor did not conduct a primary analysis; it means that analysis is not reported in the registry record.
The record does not define the primary analysis population or explain how the outcome counts relate to enrollment. It also does not report reasons for missing measurements, the method used to handle missing data, or sensitivity analyses. Consequently, the extent to which the posted summaries represent the randomized population cannot be determined from the registry information.
The detailed secondary results cover only some of the listed secondary outcomes, and the available inferential comparisons are unadjusted recalculations. The registry record does not report a multiplicity plan, the sponsor’s secondary analyses, or a hierarchy distinguishing confirmatory from exploratory outcomes. These gaps limit the weight that can be placed on the secondary p-values and on apparent agreement across outcomes.
Further trial-specific context is also not reported: the sample-size justification, randomization and allocation-concealment procedures, masking roles, detailed eligibility criteria, and longer-term outcome results. The primary endpoint is measured at Week 8 predose, so it does not describe persistence beyond that stated time point. The record does not provide a threshold for clinical importance. These limitations constrain interpretation of the registry results without implying that unreported procedures were absent from the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension — NCT02105285.
- Registry record last updated 2015-12-28; status last verified 2015-11.
- Results first posted 2015-11-17.
- 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
NCT02105285 is a completed phase 3 randomized, quadruple-masked, parallel study of OPC-1085EL ophthalmic solution and carteolol long-acting ophthalmic solution in subjects with glaucoma or ocular hypertension who were insufficiently responsive to carteolol. Both treatments are described as once daily. Enrollment is 193; the recorded study start is 2014-04 and primary completion is 2015-01.
The primary outcome is the mean decrease from baseline in intraocular pressure at Week 8 predose. The reported group means are 3.5 mmHg for OPC-1085EL and 1.6 mmHg for carteolol, with respective 95% confidence intervals of 3.1 to 3.9 and 1.2 to 2.0. A primary between-group estimate and analysis are not reported in the registry record. Detailed secondary results include unadjusted recalculated comparisons, and the record also reports adverse-event counts for three groups. Analysis populations, missing-data methods, multiplicity procedures, and the study’s sample-size justification are not reported in the registry record.