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 Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension (NCT02674854), a randomized phase 3 study. The primary outcome is Intraocular Pressure (IOP).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02674854 |
| Phase | Phase 3 |
| Condition | Open-angle Glaucoma, Ocular Hypertension |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 750 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Aerie Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
People with open-angle glaucoma or ocular hypertension and elevated intraocular pressure were eligible in principle. The registry record identifies these conditions, but detailed inclusion and exclusion criteria, baseline pressure requirements, and other eligibility details are not reported in the registry record.
Intervention
The intervention was PG324 Ophthalmic Solution 0.02%/0.005%, described as a fixed combination of netarsudil 0.02% and latanoprost 0.005% ophthalmic solution.
Comparator
The active comparators were netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%, each administered as a separate treatment group.
Primary question
The trial assessed ocular hypotensive efficacy and safety of the fixed combination compared with each component treatment. The primary outcome was mean intraocular pressure, measured at specified times over 3 months. Numerical primary outcome results and the estimated differences between treatment groups are not reported in the registry record.
The clinical question is comparative: whether the recorded intraocular-pressure measurements differed among people assigned to the combination and people assigned to either active comparator. Random allocation supports comparisons of the assigned treatment groups, subject to the trial’s conduct, missing-data handling, and analysis. The registry describes a double-masked, parallel-group design, but does not report the masking procedures or how allocation was concealed.
The record names efficacy and safety as the purposes of the study. It does not report a specific superiority, non-inferiority, or equivalence hypothesis, nor does it state a primary contrast or decision threshold. The scheduled endpoint assessments include multiple measurement times within the follow-up period, so a complete interpretation would require knowing how those measurements were combined or compared. That detail is not reported in the registry record. The record also does not report numerical group means, treatment effects, confidence intervals, or p-values. Consequently, the question can be described from the trial design, but the magnitude, direction, and precision of the primary comparison cannot be determined from the registry record.
3. Trial Design
This was a Phase 3, randomized, double-masked, multi-center, active-controlled, parallel-group study. The registry lists enrollment of 750 and describes three treatment groups: PG324 Ophthalmic Solution 0.02%/0.005%, netarsudil (AR-13324) ophthalmic solution 0.02%, and latanoprost ophthalmic solution 0.005%. The planned study duration in the official title is 3 months. The trial is listed as completed, with a start date of 2016-02 and a primary completion date of 2017-03. Aerie Pharmaceuticals is listed as the sponsor.
In a parallel-group design, participants are assigned to a treatment group and outcomes are compared across groups. Randomization is intended to make assigned groups comparable on average at the start of a study; it does not guarantee that every characteristic is balanced. Double masking is intended to limit the influence of treatment knowledge on participants and relevant study personnel, although the registry record does not describe which roles were masked or how masking was maintained. The active-controlled structure means the comparisons were against other treatments rather than against an inactive control.
The registry record does not report the randomization ratio, sequence-generation method, allocation-concealment procedure, adherence measures, rescue-treatment rules, or detailed visit schedule beyond the primary endpoint assessment times. It also does not report the trial’s protocol deviations or participant flow through follow-up. The stated enrollment is a registry value and should not be treated as the number with complete primary outcome data; the number analyzed in each treatment group is not reported in the registry record.
The arms differ in whether participants received the fixed combination or one of its component treatments. The record does not provide details sufficient to establish whether dosing schedules, administration instructions, or concomitant-care rules were identical across groups. These design details matter when assessing whether observed group differences can be attributed to assigned treatment rather than differences in study conduct. Without the numerical primary results and fuller analysis details, the design can be described, but the comparative treatment effect cannot be evaluated.
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 | PG324 Ophthalmic Solution 0.02%/0.005% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|
| STARTED | 245 | 255 | 250 |
| COMPLETED | 221 | 228 | 236 |
| NOT COMPLETED | 24 | 27 | 14 |
Reasons for not completing this period:
| Reason | PG324 Ophthalmic Solution 0.02%/0.005% | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|
| Adverse Event | 17 | 15 | 5 |
| Withdrawal by Subject | 1 | 5 | 4 |
| No-compliant subject | 1 | 0 | 1 |
| Lost to Follow-up | 1 | 0 | 2 |
| Lack of Efficacy | 0 | 3 | 0 |
| Disallowed Concurrent Medication | 2 | 2 | 0 |
| Protocol Violation | 1 | 1 | 2 |
| Death | 0 | 1 | 0 |
| Subject missed V6.2 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation
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 | PG324 Ophthalmic Solution | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% | Total |
|---|---|---|---|---|---|
| Participants analysed | 245 | 255 | 250 | 750 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 118 | 109 | 112 | 339 |
| Age, Categorical: >=65 years | Participants | 127 | 146 | 138 | 411 |
| Age, Continuous | years | 64.2 (SD 11.81) | 64.5 (SD 10.58) | 64.3 (SD 11.41) | 64.3 (SD 11.26) |
| Sex: Female, Male: Female | Participants | 152 | 153 | 144 | 449 |
| Sex: Female, Male: Male | Participants | 93 | 102 | 106 | 301 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 45 | 48 | 55 | 148 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 200 | 207 | 195 | 602 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 7 | 11 | 6 | 24 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 74 | 76 | 79 | 229 |
| Race (NIH/OMB): White | Participants | 161 | 165 | 163 | 489 |
| Race (NIH/OMB): More than one race | Participants | 2 | 3 | 0 | 5 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Intraocular Pressure (IOP), measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean intraocular pressure (IOP), reported in mmHg. The registry describes measurements at 08:00, 10:00, and 16:00 hours on Day 15, Day 43, and Day 90, using Goldmann applanation tonometry. The stated timeframe is 3 months. The primary population is the intent-to-treat (ITT) population, with Monte Carlo Markov Chain (MCMC) imputation.
IOP is a continuous measurement, so a mean summarizes the central level of the recorded measurements for a group. The standard deviation (SD), specified as the dispersion measure, describes how spread out measurements are around the mean. These summaries answer different questions: the mean characterizes average pressure, while the SD characterizes variation among measurements or participants, depending on how the endpoint data were assembled.
Repeated measurement at scheduled times can characterize pressure at different points during follow-up and at different times of day. General statistical point: repeated observations from the same participant are often related, so analysis needs to account for that dependence if it models the observations jointly. The registry record does not report whether the primary analysis used a repeated-measures model, how the scheduled readings were combined, or which time point or summary formed the principal comparison. It also does not report numerical means, SDs, treatment contrasts, or confidence intervals. Thus, the endpoint and measurement schedule are clear, while the numerical result and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies mean IOP as the primary outcome and names the ITT population with MCMC imputation. It describes measurements at three clock times on Day 15, Day 43, and Day 90. However, it does not report the primary outcome values for the treatment groups or an estimated comparison between them. There is therefore no registry-based numerical estimate from which to describe the direction or size of a treatment difference.
For a continuous outcome, a treatment contrast would ordinarily express how the groups differ in their mean outcome under a stated analysis. A confidence interval would indicate the range of values compatible with the estimate under the analysis assumptions. A p-value, if reported, would summarize how unusual data at least as incompatible with a specified null hypothesis would be under that hypothesis. These measures answer related but different questions. None of the primary treatment estimates, confidence intervals, or p-values is reported in the registry record, so neither statistical precision nor compatibility with a particular null hypothesis can be assessed.
The measurement schedule also matters to interpretation. Repeated readings across assessment days and clock times may capture different aspects of IOP, but the registry does not say whether the reported mean represents an average across scheduled readings, a comparison at particular visits, or another prespecified summary. The exact primary contrast and the model used to estimate it are not reported in the registry record. The record lists two analyses, but their individual definitions and results are not reported in the registry record.
The posted safety counts describe serious and other adverse events by treatment group, but they do not replace the missing efficacy estimates. The serious-event counts are small as reported, and the record also lists deaths by group. These counts should be read as descriptive registry data; without fuller definitions, follow-up detail, and an analysis plan, they do not establish comparative safety effects. No adjusted or unadjusted treatment effect for the primary endpoint can be reconstructed from the information in the registry record.
Accordingly, the available record supports a description of the trial question, endpoint, design, and posted adverse-event counts. It does not support a conclusion about which treatment group had lower mean IOP, how large any difference was, or how precisely the groups differed. The completion status does not itself supply the missing outcome estimates. Any interpretation of efficacy beyond the fact that efficacy was assessed would require primary results and analysis details that are not reported in the registry record.
9. Statistical Methods Explained
The primary outcome is continuous: it is a mean of IOP measurements in mmHg. The record specifies standard deviation as the dispersion measure. General explanation: a mean gives a summary of the center of a distribution, while an SD describes variation around that center. Neither summary alone describes the uncertainty in a comparison between treatment groups. That uncertainty is usually expressed using a standard error or confidence interval, with the analysis method and assumptions determining how those quantities are calculated. Numerical estimates and confidence intervals are not reported in the registry record.
What does randomization contribute?
Random allocation is a design method for reducing systematic differences between treatment groups at the point of assignment. It supports a comparison based on assigned treatment, provided that follow-up and analysis preserve the intended comparison. It does not ensure identical groups in every observed or unobserved characteristic, and it does not prevent bias arising after assignment. The registry identifies the study as randomized, but the sequence-generation and allocation-concealment methods are not reported in the registry record. The randomization ratio is also not reported.
What does masking contribute?
Double masking is intended to reduce the chance that knowledge of assigned treatment influences behavior, assessment, or reporting. General explanation: masking is most useful when participants or study personnel could affect how outcomes are measured or reported. The registry identifies the study as double-masked, but does not identify which participants, investigators, assessors, or other staff were masked. It does not report how masking was maintained or whether it was assessed. The label therefore describes the stated design, not the operational details.
How should repeated measurements be understood?
The endpoint description includes readings at 08:00, 10:00, and 16:00 hours on Day 15, Day 43, and Day 90. These are repeated measurements over time and within the day. General statistical explanation: readings from the same participant are often correlated, meaning that a person’s readings may be more similar to one another than to readings from other participants. A model that treats correlated readings as independent can misstate uncertainty. Repeated-measures models or participant-level summaries can address the structure in different ways, but the registry record does not report which approach was used, how readings were aggregated, or how within-participant correlation was handled.
What does the ITT population mean?
The primary population is described as intent to treat. General explanation: an ITT approach aims to retain participants in the groups to which they were assigned, rather than reclassifying them according to treatment received or adherence. This preserves the randomized comparison more directly, although the exact implementation depends on the analysis and availability of outcomes. The registry record does not report the numbers included in the primary analysis by group, how participants with protocol deviations were handled, or whether any additional analysis populations were used.
What is MCMC imputation?
The registry states that MCMC imputation was used for the ITT population. General explanation: imputation fills in missing values with draws from a model rather than treating each unobserved value as known. Monte Carlo Markov Chain methods generate draws through a stochastic procedure, and analyses can use the imputed datasets to reflect uncertainty about missing values. Imputation does not remove the need to state assumptions about why values are missing and how the imputation model represents the data. The model variables, number of imputations, chain settings, convergence checks, missingness patterns, and sensitivity analyses are not reported in the registry record. The imputation label alone is not enough to assess whether the assumptions were appropriate.
How should multiplicity and statistical uncertainty be considered?
The endpoint is measured at several scheduled days and clock times, and the study includes comparisons among treatment groups. General statistical explanation: when several outcomes, time points, or contrasts are tested, the chance of at least one apparently notable result can increase if no multiplicity strategy is used. Analysts may identify a primary contrast in advance, adjust inference across a family of tests, or use a hierarchical testing plan. The registry record does not report a multiplicity procedure, a testing hierarchy, the primary contrast, or whether the analyses were adjusted. It is therefore not possible to determine how any reported statistical significance would relate to multiple comparisons; no primary p-values are reported in any case.
What do the planning illustrations represent?
The planning illustrations are described as calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. General explanation: such calculations estimate the participants per arm that would be needed under the chosen assumptions; they are planning illustrations, not observed power and not evidence that the completed trial had a particular probability of detecting an effect. The registry record does not report a sample-size justification from the trial’s own design, and the observed effect and resulting planning values are not reported in the registry record. The illustrations should not be interpreted as the trial’s original enrollment rationale.
The registry record lists two analyses but does not describe their methods or report their numerical results. It does not report model covariates, handling of baseline IOP, standard errors, confidence intervals, p-values, or any adjustment for multiplicity. Those omissions limit reproducibility and prevent an independent appraisal of the primary inference from the registry record alone.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is measured at multiple scheduled times, while the study compares a fixed combination with each of its component treatments. This creates potential multiplicity across time points and treatment contrasts if several comparisons are tested. General statistical explanation: multiplicity matters because interpreting many tests without a prespecified strategy can make apparently unusual findings more likely to occur by chance. A prespecified primary contrast, a testing hierarchy, or an adjustment can help define the intended error control. The registry record does not report a multiplicity adjustment, testing hierarchy, or the specific primary contrast.
The record lists the ITT population and says MCMC imputation was used. It does not report missing-data counts, reasons for missingness, missingness by treatment group, imputation model details, or sensitivity analyses. General statistical explanation: an imputation analysis depends on assumptions about the relationship between observed information and missing outcomes. Robustness checks can help assess how sensitive conclusions are to those assumptions, but such checks are not reported in the registry record.
The record lists two analyses but does not describe their populations, models, or results. It does not report whether other analysis populations were used or how protocol deviations were treated. The number analyzed in each group is not reported in the registry record. These gaps mean that the stated ITT/MCMC approach cannot be independently reconstructed and that the impact of missing outcomes or analysis choices on the primary comparison cannot be assessed. Primary estimates and their uncertainty are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| PG324 Ophthalmic Solution | 2 | 244 | 0.8% |
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 6 | 255 | 2.4% |
| Latanoprost Ophthalmic Solution 0.005% | 5 | 251 | 2.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PG324 Ophthalmic Solution | 0 of 244 |
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 1 of 255 |
| Latanoprost Ophthalmic Solution 0.005% | 0 of 251 |
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 |
|---|---|
| PG324 Ophthalmic Solution | 157 of 244 |
| Netarsudil (AR-13324) Ophthalmic Solution 0.02% | 143 of 255 |
| Latanoprost Ophthalmic Solution 0.005% | 78 of 251 |
Most frequent serious adverse event terms
| Event term | Organ system | PG324 Ophthalmic Solution | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | 1 of 244 | 2 of 255 | 0 of 251 |
| Cardiac Failure Congestive | Cardiac disorders | 0 of 244 | 1 of 255 | 1 of 251 |
| Cardiac Arrest | Cardiac disorders | 0 of 244 | 1 of 255 | 0 of 251 |
| Coronary Artery Disease | Cardiac disorders | 1 of 244 | 0 of 255 | 0 of 251 |
| Bronchitis | Infections and infestations | 0 of 244 | 1 of 255 | 0 of 251 |
| Device Related Infection | Infections and infestations | 0 of 244 | 0 of 255 | 1 of 251 |
| Pneumonia | Infections and infestations | 0 of 244 | 0 of 255 | 1 of 251 |
| Retinal Detachment | Eye disorders | 0 of 244 | 0 of 255 | 1 of 251 |
| Cholecystitis Acute | Hepatobiliary disorders | 0 of 244 | 0 of 255 | 1 of 251 |
| Vertebral Artery Stenosis | Nervous system disorders | 0 of 244 | 1 of 255 | 0 of 251 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PG324 Ophthalmic Solution | Netarsudil (AR-13324) Ophthalmic Solution 0.02% | Latanoprost Ophthalmic Solution 0.005% |
|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | 126 of 244 | 102 of 255 | 51 of 251 |
| Instillation Site Pain | General disorders | 42 of 244 | 23 of 255 | 15 of 251 |
| Cornea Verticillata | Eye disorders | 32 of 244 | 25 of 255 | 0 of 251 |
| Conjunctival Haemorrhage | Eye disorders | 14 of 244 | 17 of 255 | 2 of 251 |
| Instillation Site Discomfort | General disorders | 15 of 244 | 16 of 255 | 2 of 251 |
| Vital Dye Staining Cornea Present | Investigations | 8 of 244 | 13 of 255 | 10 of 251 |
| Corneal Disorder | Eye disorders | 14 of 244 | 12 of 255 | 0 of 251 |
Serious events with the highest arm-level rate: atrial fibrillation (0.8%), coronary artery disease (0.4%), mental status changes (0.4%), cardiac failure congestive (0.4%), device related infection (0.4%).
The registry reports serious adverse-event counts by treatment group, including the number at risk and the number affected. For PG324 Ophthalmic Solution, 244 were at risk and 2 were affected by serious adverse events; deaths were 0. For netarsudil (AR-13324) ophthalmic solution 0.02%, 255 were at risk and 6 were affected by serious adverse events; deaths were 1. For latanoprost ophthalmic solution 0.005%, 251 were at risk and 5 were affected by serious adverse events; deaths were 0.
The record also reports other adverse-event counts: 244 at risk and 157 affected in the PG324 group, 255 at risk and 143 affected in the netarsudil group, and 251 at risk and 78 affected in the latanoprost group. The listed serious adverse-event terms and percentages are Atrial Fibrillation, 0.8%; Coronary Artery Disease, 0.4%; Mental Status Changes, 0.4%; Cardiac Failure Congestive, 0.4%; Device Related Infection, 0.4%; and Pneumonia, 0.4%. The registry does not assign these listed terms to a treatment group in the information.
These are descriptive counts, not adjusted comparisons. They do not indicate whether an event was caused by treatment, and they do not account for differences in follow-up or other factors. Event definitions, timing, and group-specific details for the listed terms are not reported in the registry record. Do not infer comparative risk by adding counts or treating these registry summaries as a complete safety analysis.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-masked, active-controlled trial assessed a fixed combination of netarsudil and latanoprost against each component treatment in people with open-angle glaucoma or ocular hypertension. It identifies mean IOP as the primary endpoint and specifies measurement times over 3 months. It also reports serious and other adverse-event counts by treatment group. These details describe what the study set out to compare and some of the posted safety data.
The record does not report the numerical primary IOP results. It therefore does not establish whether the group means were higher or lower relative to one another, how large any difference was, or how precisely a difference was estimated. It also does not report the primary confidence intervals or p-values. The study’s completed status is not a substitute for those results, and the planned enrollment does not establish how many participants contributed data to the primary analysis.
General statistical explanation: a randomized comparison can estimate the effect of assignment to the studied regimens when analyzed appropriately, but the interpretation depends on adherence, missing outcomes, measurement, and analysis choices. The registry record states that the ITT population with MCMC imputation was used, but does not give the detail needed to evaluate those choices. It does not report a specific primary contrast or a multiplicity strategy for the scheduled measurements and treatment comparisons.
The safety counts are also not causal conclusions. They describe recorded events and affected participants, but do not by themselves show whether the treatments differ in safety or whether any event was caused by treatment. The record does not provide a complete analysis of event timing, severity beyond the serious-event classification, or adjusted group comparisons.
Accordingly, the registry record supports a description of trial design, measurement, and posted event counts. It does not support a conclusion that one regimen produced a better or worse IOP outcome, nor does it establish a treatment-related safety difference. Those questions require numerical outcome results and additional analysis details that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as a design because it places a fixed combination alongside each of its component treatments in randomized, parallel groups. That structure frames comparisons of the combination regimen with netarsudil and with latanoprost as separate active-treatment questions. It is not, by itself, evidence that the combination has a particular effect or that any observed effect reflects a specific mechanism. The registry record does not report the numerical outcome estimates needed to assess these comparisons.
The endpoint involves repeated IOP measurements at different clock times and on different study days. This raises practical analysis questions about how to represent repeated observations, how to handle within-participant correlation, and how to select or combine time points. General statistical explanation: decisions about the endpoint summary can affect both the meaning of the estimate and its precision. Because the aggregation method and primary contrast are not reported in the registry record, readers cannot determine exactly which summary the principal comparison was intended to represent.
The record’s ITT designation and use of MCMC imputation also make missing-data assumptions relevant to interpretation. Imputation can preserve an analysis population, but its validity depends on the model and assumptions. Those details and sensitivity analyses are not reported. The trial therefore illustrates why naming an analysis method is useful but not sufficient for reproducibility.
Finally, the record reports safety counts but not a comparative safety analysis, and it omits numerical primary efficacy results. The statistical importance lies in separating design information from inferential evidence: randomization and masking describe how the study was organized, whereas treatment effects, uncertainty, and multiplicity handling are needed to judge what the results show. The registry record documents the former more clearly than the latter.
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 principal limitation for interpreting the trial is the absence of numerical primary outcome results in the registry record. Although the endpoint, measurement schedule, analysis population, and imputation approach are named, group means, SDs, treatment contrasts, confidence intervals, and p-values are not reported. The direction and precision of the primary comparison therefore cannot be assessed from this record.
The primary endpoint description includes repeated measurements across times of day and study days, but the method used to form or analyze the primary summary is not reported in the registry record. The primary contrast among treatment groups, model specification, handling of within-participant correlation, and multiplicity strategy are also not reported. This limits both interpretation and reproducibility.
Although MCMC imputation is named, the missing-data pattern, imputation model, model diagnostics, and sensitivity analyses are not reported in the registry record. The numbers included in the primary analysis by group and the handling of protocol deviations are not reported. The registry enrollment value should not be assumed to represent the analysis population.
Other relevant design details are not reported in the registry record, including the randomization ratio, allocation-concealment procedure, eligibility criteria beyond the named conditions, and masking procedures. The adverse-event information is descriptive; event timing and a comparative analysis are not reported. The trial is listed as completed, but completion status does not resolve these reporting gaps. These limitations concern what can be assessed from the registry record and do not establish that the trial lacked additional methods or results outside that record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension — NCT02674854.
- Registry record last updated 2019-05-21; status last verified 2019-05.
- Results first posted 2019-05-01.
- 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
NCT02674854 is a completed Phase 3 randomized, double-masked, multi-center, active-controlled, parallel-group study sponsored by Aerie Pharmaceuticals. It lists enrollment of 750 and compares PG324 Ophthalmic Solution 0.02%/0.005% with netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005% in people with open-angle glaucoma or ocular hypertension. The listed study dates are start 2016-02 and primary completion 2017-03.
The primary endpoint is mean IOP in mmHg at 08:00, 10:00, and 16:00 hours on Day 15, Day 43, and Day 90, measured by Goldmann applanation tonometry. The primary population is ITT with MCMC imputation. Serious and other adverse-event counts are reported by treatment group. Numerical primary outcome estimates, confidence intervals, p-values, and detailed statistical methods are not reported in the registry record, so comparative efficacy and precision cannot be assessed from this record alone.