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 A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia (NCT02595528), a randomized phase 2 study. The primary outcome is Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02595528 |
| Phase | Phase 2 |
| Condition | Presbyopia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 163 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Participants with presbyopia, described in the registry record as difficulty focusing on items close-up. The primary analysis population was the modified Intent-to-Treat population: randomized patients with a baseline and at least one post-baseline assessment of mesopic, high-contrast uncorrected near visual acuity.
Intervention
Concurrent use of AGN-199201 and AGN-190584 ophthalmic solutions. The study aimed to identify optimum concentrations when the products were dosed together once a day. The arm descriptions refer to vehicle and different dose combinations.
Comparator
Vehicle treatments are included in the registered interventions and arm descriptions. The registry record describes the study as vehicle-controlled, but the detailed comparison for each primary analysis is not reported in the registry record.
Primary question
How did the weighted average change from baseline in mesopic, high-contrast uncorrected near visual acuity letters differ across the treatment conditions? The registry record does not report the numerical primary outcome estimates or their uncertainty, so the size and precision of any differences cannot be determined from the posted results.
The endpoint assessed near vision without corrective lenses in the non-dominant eye. It was measured with an eye chart, with the result represented by the number of lines read correctly. The study’s stated purpose was to examine visual-acuity improvement with the combination and identify concentrations for concurrent dosing. That purpose is not itself evidence of an effect: interpretation requires the group estimates, their uncertainty, and the specified comparisons, none of which are reported for the primary outcome in the registry record.
3. Trial Design
The registry record describes a phase 2, multicenter, randomized, double-masked, vehicle-controlled study using a parallel model. Masking is recorded as quadruple. The study enrolled 163 participants and is marked completed. Its recorded start date is 2016-04-29, and its primary completion date is 2017-10-18. Allergan is listed as the sponsor.
The study concerned presbyopia and concurrent use of AGN-199201 and AGN-190584 ophthalmic solutions. The brief summary states that the aim was to identify optimum concentrations when the agents were dosed together once a day, with improvement in uncorrected near visual acuity as the target. The interventions also include the individual solutions and vehicle solutions.
There is a detail worth keeping distinct when reading the design description. Although the registry classifies the model as parallel, arm descriptions say participants were to receive five different treatments according to protocol, each for two days. They describe treatments involving AGN-199201 vehicle or Dose A alongside AGN-190584 vehicle or different doses, with eye-specific administration instructions. The descriptions available in the registry record are truncated, so the full treatment sequence and the relationship between those periods and the parallel classification are not reported in the registry record.
The record does not report the allocation ratio, the randomization procedure, the exact concentrations, or a fuller account of treatment order and any interval between dosing periods. It also does not report details sufficient to establish how masking was maintained. These omissions limit what can be inferred about implementation; they do not establish that a procedure was or was not used.
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.
Before assignment: Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study.
Overall Study
| Stage | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 |
|---|---|---|---|---|
| STARTED | 41 | 40 | 42 | 40 |
| COMPLETED | 39 | 37 | 41 | 36 |
| NOT COMPLETED | 2 | 3 | 1 | 4 |
Reasons for not completing this period:
| Reason | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 |
|---|---|---|---|---|
| Withdrawal by Subject | 1 | 2 | 1 | 3 |
| Lost to Follow-up | 1 | 1 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Modified Intent-to-Treat (mITT) population: all randomized patients who were randomized with a baseline and at least 1 post baseline assessment of mesopic, high contrast, UNVA.
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: Safety Population: all subjects who received ≥ 1 administration of study treatment
| Characteristic | Unit | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 41 | 39 | 42 | 39 | 161 | |
| Age, Continuous | Years | 46.6 (SD 2.9) | 47.1 (SD 2.7) | 46.8 (SD 2.8) | 46.7 (SD 2.3) | 46.8 (SD 2.6) |
| Sex: Female, Male: Female | Participants | 32 | 27 | 29 | 24 | 112 |
| Sex: Female, Male: Male | Participants | 9 | 12 | 13 | 15 | 49 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 7 | 11 | 3 | 9 | 30 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 34 | 28 | 39 | 30 | 131 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 | 0 | 2 |
| Race (NIH/OMB): Asian | Participants | 3 | 1 | 0 | 0 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 6 | 13 | 3 | 28 |
| Race (NIH/OMB): White | Participants | 32 | 30 | 28 | 36 | 126 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Baseline UNVA severity: ≤ 20/80 | Participants | 26 | 28 | 28 | 26 | 108 |
| Baseline UNVA severity: > 20/80 | Participants | 15 | 11 | 14 | 13 | 53 |
6. Primary Endpoint
The registry lists the primary outcome as Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters, measured over Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | Standard Error |
| Unit | letters correctly read |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was the weighted average change from baseline in mesopic, high-contrast uncorrected near visual acuity letters. It was measured without corrective lenses in the non-dominant eye using an eye chart. The endpoint is expressed as the number of letters read correctly, and the registry description explains that reading more lines correctly represents better visual acuity.
The timeframe was baseline and assessments between hour 1 and hour 10 of each of the five 2-day dosing periods. A weighted average combines measurements across the specified assessment window into a summary measure; the registry record does not describe the weights used. The registered outcome parameter is a least-squares mean, with standard error listed as the measure of dispersion.
Near visual acuity is relevant to the stated study aim because the study sought to assess uncorrected near vision in participants with presbyopia. A change-from-baseline measure expresses the outcome relative to each participant’s baseline assessment, while a comparison between treatment conditions would be needed to describe differences associated with those conditions. The numerical endpoint estimates, standard errors, and detailed comparisons are not reported in the registry record. Therefore, the endpoint’s direction is interpretable from its definition, but the observed magnitude and precision are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a continuous primary outcome and its measurement method, but it does not report the primary outcome values. In particular, it does not give the least-squares mean changes, standard errors, confidence intervals, or the results of the treatment comparisons. Without those results, the size of any observed change and the precision with which it was estimated cannot be evaluated from the record.
The endpoint is defined so that an increase in the number of correctly read letters indicates better visual acuity. That direction helps explain what an estimate would mean, but it does not establish whether any treatment condition produced a larger change than another. Nor does the study’s stated goal of identifying optimum concentrations tell the reader which concentrations, if any, had the most favorable observed outcome. Those conclusions require reported estimates and comparisons.
The study enrolled 163 participants, but enrollment alone does not show how many contributed to each endpoint analysis or how observations were distributed across treatment conditions. The primary analysis population is described as the modified Intent-to-Treat population, requiring randomization, a baseline measure, and at least one post-baseline assessment. The number included in that population is not reported in the registry record.
The safety data report serious adverse events affecting 1 participant in the vehicle and AGN-199201 group, 1 in the lower-dose group, 0 in the medium-dose group, and 1 in the higher-dose group. The corresponding numbers at risk are 41, 39, 42, and 39. The record lists no deaths in any group. Other adverse events affected 9, 9, 16, and 17 participants, respectively, with those same group denominators. These are counts, not comparative estimates of risk, and the registry record does not provide enough information to determine whether events were caused by treatment or how groups were formally compared.
General statistical interpretation: an estimate describes the observed result in the analyzed data, while a confidence interval describes uncertainty around that estimate under the analysis assumptions. The standard error is one measure related to that uncertainty. Since the primary estimates and their uncertainty are not reported in the registry record, no conclusion about statistical significance, precision, or comparative effect can be drawn from the primary endpoint information.
9. Statistical Methods Explained
What does a least-squares mean represent?
The primary outcome parameter is a least-squares mean. General explanation: a least-squares mean is an estimated group mean from a statistical model, often adjusted for variables included in that model. Its interpretation depends on the model specification and the data used. The registry record does not describe the model, any covariates, or the estimation procedure, so it is not possible to identify what adjustments were made or reproduce the estimate from the record.
The outcome is a continuous measure: a count of letters read correctly, analyzed as change from baseline and combined into a weighted average over the stated assessment window. The registry record does not explain the weights used to form that average. It also does not report the numerical least-squares means. As a result, the measure and its intended direction can be described, but the estimated change cannot be interpreted quantitatively.
What does the standard error tell the reader?
The registry lists standard error as the dispersion measure for the primary endpoint. General explanation: a standard error describes the estimated sampling variability of an estimate under the analysis method. A smaller standard error generally indicates a more precisely estimated mean, while a larger one indicates greater uncertainty. It is not the same as the spread of individual participant measurements. The actual standard errors are not reported in the registry record, so the precision of the primary estimates cannot be assessed.
Confidence intervals are commonly used to show a range of values compatible with an estimate under the analysis assumptions. General explanation: a confidence interval combines the estimated effect and its uncertainty, and its width conveys precision. The registry record does not report confidence intervals for the primary outcome. No interval can be inferred from the endpoint description alone.
Why does the repeated assessment structure matter?
The endpoint timeframe covers assessments between hour 1 and hour 10 of each of five 2-day dosing periods. Multiple assessments within participants are not necessarily independent observations. General explanation: when repeated measurements are analyzed, the statistical method may need to account for their correlation within the same participant. The registry record does not state how repeated measurements, periods, or treatment sequence were handled in the primary analysis. It is therefore not possible to judge whether or how those features were incorporated in the model.
The arm descriptions indicate five treatments per participant, each for two days, while the design classification is parallel. These details make the analysis structure important to understand, but the full protocol and model are not reported in the registry record. The treatment order, any interval between periods, and any handling of possible period or carryover effects are also not reported in the registry record. These are questions for the analysis specification, not matters that can be resolved from the outcome label.
What is the role of the planning illustrations?
The planning assumptions describe an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated target effect is a specified fraction of the observed effect. General explanation: such calculations estimate the sample size that would be needed to detect an effect under chosen assumptions. They are planning scenarios, not evidence that the trial had a particular probability of detecting an effect, and not a substitute for the observed outcome results.
The registry record does not report the primary outcome estimate needed to understand the observed effect underlying those illustrations, nor does it report the trial’s own sample-size justification. The illustrations therefore should not be read as the protocol’s design rationale. No sample-size figure can be interpreted without its assumptions, and these assumptions apply to the illustration rather than necessarily to the original trial planning.
What can be said about the analysis plan?
The registry record describes the primary analysis population as randomized participants with a baseline and at least one post-baseline assessment. It also lists four analyses, but their individual specifications and numerical results are not reported in the registry record. The record does not state which statistical tests were used, how comparisons were organized, whether any adjustment was made for multiple testing, or how missing outcome data were handled. Those omissions prevent a full appraisal of the statistical analysis plan.
General explanation: multiplicity arises when several hypotheses or comparisons are evaluated; without appropriate planning, the chance of at least one false-positive finding can increase. The extent of that issue depends on the number and relationship of comparisons and on the analysis strategy. The registry record does not describe those elements sufficiently to determine how multiplicity was addressed. Similarly, missing-data methods can affect estimates if some assessments are unavailable; the record does not describe any imputation or other handling method.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies a modified Intent-to-Treat population for the primary endpoint: all randomized patients with a baseline and at least one post-baseline assessment of mesopic, high-contrast uncorrected near visual acuity. This definition means the stated analysis population excludes randomized patients without the required post-baseline assessment. The number of participants meeting the definition is not reported in the registry record, and the record does not give the number of missing assessments or explain why measurements might be absent.
The endpoint covers repeated measurements during each of five 2-day dosing periods. The registry record does not explain how incomplete measurement series were handled, whether participants with partial data contributed to the weighted average, or whether any imputation or model-based method was used. These details matter because the analysis population definition alone does not specify how missing values were treated.
The record lists four analyses, but their exact contrasts and inferential procedures are not reported in the registry record. It does not describe whether the analyses were considered a family of comparisons, whether a multiplicity adjustment was applied, or how the primary comparison was selected. General explanation: multiple comparisons can complicate interpretation because the more hypotheses examined, the greater the opportunity for an apparently unusual result to occur by chance. An adjustment or prespecified testing strategy can address that concern, but neither should be assumed in the absence of a report.
The registry record also does not report the detailed statistical analysis plan, the primary comparison’s test, or the handling of any deviations from the planned analysis population. These absences limit assessment of the robustness and reproducibility of the reported analysis; they do not establish that the trial lacked a plan or that any particular method was used.
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 |
|---|---|---|---|
| AGN-190584 Vehicle and AGN-199201 | 1 | 41 | 2.4% |
| AGN-190584 Lower Dose and AGN-199201 | 1 | 39 | 2.6% |
| AGN-190584 Medium Dose and AGN-199201 | 0 | 42 | 0.0% |
| AGN-190584 Higher Dose and AGN-199201 | 1 | 39 | 2.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AGN-190584 Vehicle and AGN-199201 | 0 of 41 |
| AGN-190584 Lower Dose and AGN-199201 | 0 of 39 |
| AGN-190584 Medium Dose and AGN-199201 | 0 of 42 |
| AGN-190584 Higher Dose and AGN-199201 | 0 of 39 |
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 |
|---|---|
| AGN-190584 Vehicle and AGN-199201 | 9 of 41 |
| AGN-190584 Lower Dose and AGN-199201 | 9 of 39 |
| AGN-190584 Medium Dose and AGN-199201 | 16 of 42 |
| AGN-190584 Higher Dose and AGN-199201 | 17 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 |
|---|---|---|---|---|---|
| Cervix carcinoma stage 0 | Investigations | 1 of 41 | 0 of 39 | 0 of 42 | 0 of 39 |
| Cholecystitis | Hepatobiliary disorders | 0 of 41 | 1 of 39 | 0 of 42 | 0 of 39 |
| Malignant melanoma | Musculoskeletal and connective tissue disorders | 0 of 41 | 0 of 39 | 0 of 42 | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AGN-190584 Vehicle and AGN-199201 | AGN-190584 Lower Dose and AGN-199201 | AGN-190584 Medium Dose and AGN-199201 | AGN-190584 Higher Dose and AGN-199201 |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 5 of 41 | 4 of 39 | 8 of 42 | 7 of 39 |
| Punctate keratitis | Eye disorders | 2 of 41 | 1 of 39 | 4 of 42 | 2 of 39 |
| Instillation site pain | General disorders | 3 of 41 | 0 of 39 | 1 of 42 | 3 of 39 |
| Upper respiratory tract infection | Infections and infestations | 0 of 41 | 2 of 39 | 3 of 42 | 1 of 39 |
| Visual impairment | Eye disorders | 1 of 41 | 0 of 39 | 1 of 42 | 4 of 39 |
| Lacrimation increased | Eye disorders | 0 of 41 | 3 of 39 | 2 of 42 | 0 of 39 |
| Foreign body sensation in eyes | Eye disorders | 1 of 41 | 2 of 39 | 0 of 42 | 0 of 39 |
| Visual acuity reduced | Eye disorders | 0 of 41 | 0 of 39 | 1 of 42 | 2 of 39 |
| Vitreous floaters | Eye disorders | 0 of 41 | 0 of 39 | 0 of 42 | 2 of 39 |
Serious events with the highest arm-level rate: cholecystitis (2.6%), malignant melanoma (2.6%), cervix carcinoma stage 0 (2.4%).
The registry safety counts are organized by AGN-190584 vehicle, lower dose, medium dose, and higher dose, each with AGN-199201. Serious adverse events affected 1 of 41 participants in the vehicle group, 1 of 39 in the lower-dose group, 0 of 42 in the medium-dose group, and 1 of 39 in the higher-dose group. The record reports 0 deaths in each group.
Other adverse events affected 9 of 41 participants in the vehicle group, 9 of 39 in the lower-dose group, 16 of 42 in the medium-dose group, and 17 of 39 in the higher-dose group. These figures count participants affected; they do not give the total number of event episodes. The registry record does not provide event-level details or a statistical comparison of these groups in the safety information.
The record also lists Cholecystitis, Malignant melanoma, and Cervix carcinoma stage 0 among the top serious terms, with percentages of 2.6%, 2.6%, and 2.4%, respectively. The denominator and calculation context for these percentages are not reported in the registry record. Adverse-event counts alone do not establish causation, and the registry record does not establish that the events were caused by study treatment.
12. What the Result Does, and Does Not, Mean
The information in the registry record establishes the study’s question, design classification, endpoint definition, analysis population, and selected safety counts. It does not report numerical results for the primary visual-acuity endpoint. Consequently, the magnitude of the outcome change, the difference between treatment conditions, and the precision of any estimated difference cannot be judged from this record.
The endpoint definition gives a clear direction: more correctly read letters represent better visual acuity. But an outcome’s direction is not an outcome result. The stated aim to identify optimum concentrations describes what the study sought to investigate; it does not identify which concentration had the largest or most precise observed effect. No such ranking or treatment comparison should be inferred without the numerical estimates and analysis details.
The safety information gives counts of participants affected by serious and other adverse events and reports no deaths in the listed groups. Those observations describe what was recorded, but they do not by themselves establish whether differences between groups are meaningful or whether any event was caused by treatment. The listed serious-event terms and percentages also lack the context needed for a fuller interpretation.
General explanation: a trial result is most informative when the estimated effect, its uncertainty, the analysis population, and the comparison being made are all clear. An estimate without uncertainty can be difficult to assess, while a comparison without a clearly described analysis may be difficult to reproduce. In this record, the primary numerical estimates and important analysis details are not reported in the registry record.
Accordingly, the posted information supports a description of the planned clinical question and the available safety counts, but it does not support a quantitative conclusion about the primary endpoint. It also does not establish the clinical importance of any possible difference. The absence of those details in the registry record should be treated as a reporting limitation, not as evidence that an effect was absent or present.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it examines a continuous visual-acuity endpoint across multiple dosing periods and treatment conditions. The endpoint combines repeated assessments into a weighted average, and its interpretation depends on how those observations were summarized and analyzed. Understanding the statistical approach would help readers distinguish a treatment-condition estimate from the underlying variability in participant measurements.
The record labels the primary parameter as a least-squares mean and the dispersion as standard error. Those labels point to an estimated mean and a measure of its precision, but the model and numerical estimates are not reported in the registry record. Without them, readers cannot assess how precisely the primary outcome was estimated or compare the conditions on the stated endpoint.
The combination of a parallel-model classification and arm descriptions involving five treatments per participant also makes clarity about treatment sequence and repeated-measure analysis important. The registry record does not provide the full sequence or explain how periods and repeated assessments entered the analysis. This is a useful reminder that design labels do not by themselves convey every feature needed to understand an analysis.
Finally, the stated planning illustrations are distinct from the trial’s own design justification and from observed results. They use an observed-effect basis and specified assumptions, but the registry record does not report the underlying primary estimate or the original sample-size justification. Separating planning scenarios from observed evidence is important for avoiding overinterpretation.
The trial therefore highlights several questions that apply broadly to clinical research: are the outcome estimates and uncertainty reported, are repeated observations handled transparently, and are the population and comparison clearly defined? Those details are necessary for readers to evaluate the strength and precision of a statistical result.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial from the registry record is that numerical results for the primary endpoint are not reported. The record does not provide the least-squares mean changes, standard errors, confidence intervals, or the numerical treatment comparisons. Thus, neither the effect size nor its precision can be evaluated.
The primary outcome is a weighted average across assessments between hour 1 and hour 10 of each of five 2-day dosing periods, but the weighting procedure is not reported in the registry record. The record also does not describe the primary statistical model, treatment contrasts, or how repeated measurements were handled. These omissions make it difficult to reproduce or fully assess the analysis.
The registry classifies the model as parallel, while the arm descriptions state that participants received five treatments according to protocol, each for two days. The full sequence is not reported in the registry record. The record also does not describe treatment order, any interval between periods, or how possible period effects were considered. The available arm descriptions are truncated, so the complete dosing procedures and exact concentrations are not established by the record.
The modified Intent-to-Treat definition is stated, but the number analyzed and the extent or handling of missing outcome data are not reported in the registry record. Multiplicity procedures and details of the four listed analyses are likewise not reported. These gaps limit interpretation of the analysis population and of any potential set of comparisons.
Safety information is limited to group counts, deaths, and selected serious-event terms with percentages. The record does not give context for the percentages or detailed event-level information in the safety summary. These limitations concern the information available in the registry record; they do not demonstrate that the trial did not collect or analyze additional data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia — NCT02595528.
- Registry record last updated 2020-12-22; status last verified 2020-11.
- Results first posted 2020-12-22.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02595528 is a completed phase 2, multicenter, randomized, double-masked, vehicle-controlled study of concurrent AGN-199201 and AGN-190584 in participants with presbyopia. The registry classifies the model as parallel and masking as quadruple. Enrollment was 163; Allergan is listed as sponsor. The recorded start date is 2016-04-29, and the primary completion date is 2017-10-18.
The primary endpoint was weighted average change from baseline in mesopic, high-contrast uncorrected near visual acuity letters, assessed in the non-dominant eye. The primary analysis population was the modified Intent-to-Treat population. Numerical results for this endpoint and key statistical analysis details are not reported in the registry record.
Safety counts include serious and other adverse events by vehicle and dose group, with 0 deaths reported in each group. These counts are descriptive and do not establish causation or comparative risk.