Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia (NCT05665387), a randomized phase 2 study. The primary outcome is Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA).

2. Clinical Question

3. Trial Design

The registry identifies NCT05665387 as a completed Phase IIa study of STN1013600 ophthalmic solution for presbyopia. Its official title describes a randomized, double-masked, placebo-controlled, parallel-group, multicenter study. The reported enrollment was 79. The study began on 2022-12-22, and the primary completion date was 2023-07-27.

There were three groups: 0.1% STN1013600, 0.3% STN1013600, and placebo vehicle. The treatment descriptions specify one drop twice daily for both active concentrations and twice-daily placebo. The brief summary describes a screening period of up to 15 days, followed by a 2 Month Treatment Period and a one-month treatment-free follow-up. These are the durations described in the registry summary; additional visit schedules or operational details are not reported in the registry record.

The parallel-group structure means each participant was assigned to one group rather than receiving the study treatments in sequence. Randomization is intended to support a fair comparison between assigned groups, while masking is intended to reduce the influence of treatment knowledge on participants and study conduct. The registry identifies double masking but does not state which roles were masked or describe the masking procedures.

The primary outcome was mean change from baseline in binocular distance-corrected near visual acuity at Month 2. The registry describes its analysis as using a Bayesian approach in the Analysis Population. It also reports group means and standard errors, but does not report numerical Bayesian posterior estimates or a detailed statistical analysis plan. The original sample-size justification and the trial's planned allocation ratio 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) included all randomized subjects. The number analyzed are participants evaluable for the outcome measure at Month 2.

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.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline in Binocular Distance Corrected Near Visual Acuity (DCNVA), measured over At Month 2.

The primary endpoint is mean change from baseline in binocular distance-corrected near visual acuity, or DCNVA, at Month 2. The measure is reported in EDTRS letters. It assesses near visual acuity while distance correction is used, with binocular measurement referring to assessment using both eyes. The endpoint is a continuous measure: each participant contributes a numerical value, and the group result is expressed as a mean change.

Change from baseline focuses the comparison on how the measurement shifted during the study rather than on the Month 2 measurement alone. A mean summarizes the group's average change, while the standard error describes the precision of that estimated mean. The registry says the primary analysis included all randomized subjects in the Full Analysis Set, with the number analyzed determined by who was evaluable for the outcome at Month 2. The arm-specific analyzed counts were 30 for 0.3%, 33 for 0.1%, and 15 for placebo.

As a general statistical point, a continuous endpoint can capture gradations in change rather than reducing results to a yes-or-no category. Its interpretation still depends on the measure's context, the magnitude and uncertainty of the estimated differences, and the analysis plan. The registry record does not report a threshold for a clinically meaningful change, so the posted mean changes alone cannot establish how important a particular difference would be to participants.

7. Results Posted in the Registry

• 0.3% STN1013600 Ophthalmic Solution: mean 4.10 versus 4.40 on control; difference -0.30 (95% CI -3.59 to 2.99), standardized effect d = -0.05; z-test p = 0.858.
• 0.1% STN1013600 Ophthalmic Solution: mean 4.30 versus 4.40 on control; difference -0.10 (95% CI -3.30 to 3.10), standardized effect d = -0.02; z-test p = 0.951.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • 0.3% STN1013600 Ophthalmic Solution: mean -7.49 versus -10.51 on control; difference 3.02 (95% CI -4.48 to 10.52), standardized effect d = 0.25; z-test p = 0.430.
  • 0.1% STN1013600 Ophthalmic Solution: mean -8.14 versus -10.51 on control; difference 2.37 (95% CI -5.03 to 9.77), standardized effect d = 0.20; z-test p = 0.530.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between 0.3% STN1013600 Ophthalmic Solution and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between 0.1% STN1013600 Ophthalmic Solution and the control. The interval gives the range of effects that remain compatible with the data.

Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • 0.3% STN1013600 Ophthalmic Solution: 43.3% (13/30) versus 60.0% (9/15) on control; risk difference -16.7 percentage points (95% CI -47.1 to 13.8), risk ratio 0.72 (0.40–1.29); unadjusted two-proportion z-test p = 0.292.
  • 0.1% STN1013600 Ophthalmic Solution: 54.5% (18/33) versus 60.0% (9/15) on control; risk difference -5.5 percentage points (95% CI -35.5 to 24.6), risk ratio 0.91 (0.54–1.53); unadjusted two-proportion z-test p = 0.724.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between 0.3% STN1013600 Ophthalmic Solution and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between 0.1% STN1013600 Ophthalmic Solution and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several aspects beyond the primary binocular acuity measure: study-eye DCNVA, the proportion achieving specified line improvements in study-eye and binocular DCNVA, quality of life assessed with the Near Activity Visual Questionnaire (NAVQ), and treatment satisfaction assessed by a patient global rating. The posted numerical results described in the registry include NAVQ change and participant counts for treatment satisfaction. Results for the line-improvement outcomes and the listed study-eye DCNVA outcome are not reported in the registry record.

At a broad level, the reported secondary summaries do not supply a clear, consistent basis for a stronger conclusion than the primary result. The NAVQ comparisons have intervals spanning values in both directions, and the satisfaction comparisons are also imprecise. These measures concern different constructs from binocular DCNVA, so they can add context but do not replace the primary endpoint. Nor can they establish a comprehensive pattern when some listed outcomes lack numerical results.

Secondary outcomes are often useful for exploring whether an intervention's effects appear across different domains, but interpretation becomes more difficult when many outcomes and comparisons are examined. Without a reported multiplicity strategy, unadjusted secondary results carry less weight as confirmatory evidence. A nominal result can arise by chance when many comparisons are considered, and selecting only favorable findings would exaggerate certainty. The registry does not report adjusted secondary analyses or a hierarchy that would establish which secondary outcomes were confirmatory. The secondary findings are best treated as contextual and exploratory rather than as independent confirmation of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change From Baseline in Study Eye Distance Corrected Near Visual Acuity (DCNVA) at Month 2
• Percentage of Participants Who Improved 1/2/3-lines or More in Study Eye and Binocular Distance Corrected Near Visual Acuity (DCNVA) at Month 2
• Mean Change From Baseline in Quality of Life Assessed With Near Activity Visual Questionnaire (NAVQ) at Month 2
• Subject Treatment Satisfaction as Assessed by Patient Global Rating of Treatment

9. Statistical Interpretation

10. Statistical Methods Explained

Several statistical ideas help explain what the reported results do and do not convey. The primary outcome is continuous, and the registry reports an arm-specific mean change and standard error for each group. A mean is the arithmetic center of the observed values in a group. It offers a compact description, but it does not show how individual participants' results were distributed. The standard error describes uncertainty in the estimated mean; it is not the range of individual outcomes.

What does a between-group estimate mean?

The mean difference compares the reported group means. For the primary outcome, the contrast is expressed as active treatment minus placebo. A negative estimate therefore corresponds to a lower mean change in the active-treatment group in these posted summaries. The estimate is a point estimate: it gives one best summary of the observed contrast, but it is not known without uncertainty. An interval around it expresses a range of values compatible with the data under the method used to construct that interval.

For 0.3% versus placebo, the reported estimate is -0.3, and its interval extends from -3.588 to 2.988. For 0.1% versus placebo, the estimate is -0.1, and its interval extends from -3.302 to 3.102. Both intervals cross zero. As a general statistical explanation, an interval that includes zero does not provide a precise directional distinction between groups. It does not prove there is no difference; the interval can include meaningful values in more than one direction. The registry record does not report the interval's confidence level or the details of how these comparison intervals were calculated.

What does a p value contribute?

The unadjusted p values for the primary contrasts are 0.858 and 0.951. In general, a p value describes how compatible the observed data are with a specified null model, given the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of a difference. The registry calls the primary analysis Bayesian, while the posted comparisons include unadjusted p values. The record does not explain how those comparison summaries relate to the stated Bayesian analysis, nor does it report a complete primary analysis output. They should therefore be read as unadjusted comparison statistics, not as a substitute for unreported Bayesian results.

Why does the analysis population matter?

The registry defines the Full Analysis Set as including all randomized subjects, and says that the number analyzed for the primary outcome is the number evaluable at Month 2. That distinction matters: the analysis population can be defined broadly while the outcome-specific analysis count is smaller if some participants do not have an evaluable outcome. The record does not describe missing observations, reasons for non-evaluation, imputation, or sensitivity analyses. It is therefore not possible to assess from the registry record how missing outcome data were handled or whether alternative assumptions were tested.

Group counts for the primary outcome were 30, 33, and 15, while the reported overall enrollment was 79. The registry does not give an accounting that reconciles these figures. Rather than infer why the counts differ, readers should note that the primary estimates are based on the stated evaluable numbers and that the reason for any difference from enrollment is not reported in the registry record.

What does the Bayesian description tell readers?

A Bayesian analysis combines observed data with a prior distribution to describe uncertainty about quantities of interest. In general, results may be expressed using posterior estimates or credible intervals. The registry states that the primary analysis used a Bayesian approach, but its posted primary description does not include numerical posterior summaries, the prior specification, or details of the model. Without those elements, the Bayesian analysis cannot be independently interpreted from the reported group means and standard errors alone. General explanations of Bayesian methods do not identify which specific choices were made for this trial.

The standard errors reported for the primary means are 1.24 for 0.3%, 1.18 for 0.1%, and 1.13 for placebo. These describe uncertainty in the arm-level means, not the variability of individual participants' measurements. The registry does not report the within-group standard deviations for the primary endpoint. Nor does it report diagnostics, model checks, handling of multiplicity, or interim analyses. Those omissions limit assessment of the analytic process but do not alter the values that are posted.

More generally, a well-defined analysis plan helps specify the population, outcome, treatment contrasts, missing-data approach, and inferential procedure before results are known. That protects interpretation from selective emphasis among many possible analyses. The registry record does not report the trial's complete statistical plan, original sample-size justification, or any interim-analysis plan. These details should not be inferred from the fact that the study was randomized or from the statistical summaries that were posted.

11. Confidence Intervals and Precision

The primary comparison intervals are wide relative to their point estimates. For 0.3% versus placebo, the reported mean difference is -0.3, with an interval from -3.588 to 2.988. For 0.1% versus placebo, the mean difference is -0.1, with an interval from -3.302 to 3.102. Each interval includes zero and values both below and above zero. The estimates therefore provide limited precision about the direction and size of the between-group difference.

In general, an interval conveys uncertainty around an estimate under a specified statistical method. A narrower interval would indicate greater precision under that method; a wider interval indicates that the data are consistent with a broader range of values. The interval does not show the range of individual participants' outcomes, and it does not guarantee that the true value lies within its limits. The registry record does not specify the confidence level or construction method for the posted comparison intervals, so these should be interpreted as reported rather than assigned an unreported label.

The arm-specific standard errors are 1.24, 1.18, and 1.13 for 0.3%, 0.1%, and placebo, respectively. The primary analysis counts are 30, 33, and 15. Limited information, especially in the placebo group, contributes to uncertainty in comparisons. Precision is not the same as clinical importance: a precisely estimated difference could be small, while a less precise estimate can leave a wide range of possibilities unresolved. The record does not report a clinically meaningful difference threshold, so the intervals cannot be judged against such a threshold.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effects, not the trial's original design assumptions. For these continuous outcomes, the figures are participants per arm, rather than total events. The calculations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They show planning scenarios for detecting 100%, 75%, or 50% of the observed effect. The trial's own sample-size justification and original planning assumptions are not reported in the registry record.

The 80% power column represents the number of participants per arm that the illustration estimates would be needed for an 80% chance of detecting the specified effect under its assumptions. The 90% power column uses a higher target chance of detection and therefore generally calls for more participants per arm. These are prospective design concepts: they describe what a hypothetical study might plan for, not what happened in this completed trial.

Rows for smaller fractions of the observed effect require more participants because smaller differences are harder to distinguish from random variation. The figures also depend strongly on the size of the observed effect, which is especially close to zero for the primary contrasts. For that reason, the resulting planning counts can become very large; they should not be interpreted as a recommendation or as a validated redesign of this study. This is not observed power. It is a set of hypothetical calculations under the stated assumptions, and different assumptions or target effects would produce different planning figures.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.300; pooled standard deviation σ = 6.111.
2. n = 2 × (1.96 + 0.842)² × 6.111² / -0.300² = 6,513.8, rounded up to 6,514 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.300000000000001                      # observed difference in means
sigma <- 6.1111050270113                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5665387)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 6,514 (80% power), 8,721 (90% power)
 75% of observed effect: n per arm = 11,581 (80% power), 15,503 (90% power)
 50% of observed effect: n per arm = 26,056 (80% power), 34,881 (90% power)
power.t.test: 6514.8 
Simulated power at n = 6,514 per arm: 0.803 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and several secondary outcomes, including visual acuity, line improvement, quality of life, and treatment satisfaction. Examining multiple outcomes and treatment contrasts raises a multiplicity question: as the number of statistical comparisons grows, the chance of at least one apparently notable result by chance can increase. Statistical plans often address this by defining a hierarchy, adjusting inference, or explicitly treating secondary analyses as exploratory. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a complete plan for interpreting the several outcomes.

The posted secondary comparisons are labeled by unadjusted p values. Those values do not account for the full set of outcomes or comparisons unless a method is specified, and no such method is reported. They should not be read as confirmatory evidence in isolation. The registry also does not report numerical results for all the named secondary outcomes, including the line-improvement measures and study-eye DCNVA results in the information available for this trial.

Missing-data handling is another important uncertainty. The primary outcome description says the Full Analysis Set included all randomized subjects, while the number analyzed was the number evaluable at Month 2. The registry does not describe the amount or pattern of missing outcome data, reasons for missingness, imputation, or sensitivity analyses. It is not possible to determine from the record whether missingness could have affected the estimates.

The record states that the primary analysis used a Bayesian approach but does not report the prior, model details, posterior summaries, or model diagnostics. It does not report interim analyses or the original sample-size justification. These are unreported details, not evidence that a particular method was or was not used. Their absence limits independent appraisal of the analysis and of how the outcomes were selected and interpreted.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety figures report zero serious adverse events in each group: 0 among 30 participants in the 0.3% group, 0 among 33 in the 0.1% group, and 0 among 16 in the placebo group. The registry also reports zero deaths in each group and lists no serious adverse-event terms. The safety denominators differ from the primary outcome counts, and the reason for that difference is not reported in the registry record.

Zero reported serious events in a small study means none were recorded in the stated groups during the reporting period; it does not establish that serious events cannot occur or precisely estimate their frequency. Rare events are difficult to characterize with limited exposure and follow-up. The registry also lists other adverse events affecting 7 participants in the 0.3% group, 9 in the 0.1% group, and 2 in placebo. These are separate from the serious-event counts and should not be conflated with them. The record does not provide enough detail to assess event types, timing, severity within the other category, or causal attribution.

16. What the Result Does, and Does Not, Mean

The posted primary results describe mean change in binocular distance-corrected near visual acuity at Month 2 among participants evaluable for that outcome. The group means were 4.1, 4.3, and 4.4 EDTRS letters for 0.3%, 0.1%, and placebo. The unadjusted contrasts were close to zero, and their intervals were broad enough to include differences in either direction. This is a description of the results and their precision, not a claim that either treatment works or does not work.

The results do not establish equivalence between STN1013600 and placebo. Equivalence requires a defined margin and an analysis that evaluates whether the uncertainty is contained within that margin; neither is reported in the registry record. Likewise, the estimates do not establish that an effect is absent. The intervals leave uncertainty about the possible size and direction of the differences.

The trial addresses a specific population, measure, and time point. Its primary question concerns Month 2 binocular DCNVA change, not every aspect of near vision, quality of life, satisfaction, safety, or outcomes over longer periods. The registry describes a one-month treatment-free follow-up, but the posted primary result is at Month 2. Longer-term efficacy results are not reported in the registry record.

The study was Phase IIa and enrolled 79 participants, with primary outcome analysis counts of 30, 33, and 15. Such results can inform understanding of uncertainty and provide a basis for further research questions, but they do not by themselves resolve effects across broader populations or settings. The registry does not report a clinically meaningful threshold for the primary measure, so the practical importance of a particular numerical contrast cannot be determined from these summaries alone.

Finally, an interpretation should distinguish the registry's stated Bayesian primary approach from the unadjusted comparison summaries. Numerical posterior results and analysis details are not reported. This limits how fully the primary inferential analysis can be evaluated from the record. The secondary outcome information is also incomplete, and the safety counts do not characterize uncommon risks with precision.

17. Why This Trial Matters Statistically

This trial is statistically instructive because its point estimates are close to zero while their intervals remain broad. That combination illustrates why an estimate alone is not enough: the numerical center and the uncertainty around it both matter. A small point estimate does not show that all plausible differences are small, and an interval spanning both directions does not settle which direction, if any, is true.

The unequal outcome-analysis counts are also relevant to interpretation. The primary outcome was analyzed in 30 participants in the 0.3% group, 33 in the 0.1% group, and 15 in placebo. In general, group size affects how precisely a contrast can be estimated, and fewer observations in one group can leave the comparison less certain. The registry does not explain the difference between enrollment and the outcome-specific counts, making transparent reporting of analysis populations and missingness important.

The trial is described as Bayesian, yet numerical posterior results and key analysis details are not included in the registry record. This creates a useful distinction between a named analytic approach and the information needed to assess its implementation. The posted group summaries and unadjusted contrasts communicate part of the evidence, but do not replace the missing posterior output or a complete analysis plan.

Finally, multiple secondary outcomes make multiplicity and selective interpretation important statistical considerations. Some secondary results are posted, while other named outcomes lack results in the registry record. Taken together, the study demonstrates why precision, analysis-population reporting, completeness of results, and the match between stated methods and reported outputs all matter when interpreting a clinical trial.

18. 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.

Several trial-specific limitations follow from the registry information. The primary outcome analysis counts were 30, 33, and 15, and the placebo group was smaller than either active-treatment group. The reported intervals are broad, leaving uncertainty about the size and direction of the comparisons. The registry reports overall enrollment of 79 but does not explain how the outcome-specific counts relate to enrollment.

The primary analysis is described as Bayesian, but numerical Bayesian summaries, the prior, model specifications, and diagnostics are not reported. The comparison summaries include unadjusted p values, and the record does not explain their relationship to the stated Bayesian analysis. The confidence level and construction of the reported intervals are also not stated in the registry information.

Important operational and analytic details are not reported in the registry record, including the original sample-size justification, complete statistical plan, handling of missing data, interim analyses, and multiplicity strategy. The record does not report a clinically meaningful threshold for the primary endpoint. Some named secondary outcomes have no numerical results in the posted record, limiting a full assessment across endpoints.

Safety interpretation is constrained by the small group counts and by limited details about event types and follow-up. Zero serious events were reported in each group, but these counts cannot precisely characterize uncommon events. The record describes treatment and follow-up duration, but does not provide longer-term primary outcome results. These limitations describe what the registry record does not establish; they do not indicate that unreported procedures or analyses were necessarily absent.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With Presbyopia — NCT05665387.
• Registry record last updated 2024-05-29; status last verified 2024-05.
• Results first posted 2024-05-29.
• 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.

22. Record Summary

NCT05665387 is a completed Phase IIa randomized, double-masked, placebo-controlled, parallel-group study of STN1013600 ophthalmic solution for presbyopia. Reported enrollment was 79. The trial compared 0.1% and 0.3% solution, each described as one drop twice daily, with twice-daily placebo vehicle.

The primary outcome was mean change from baseline in binocular DCNVA at Month 2, measured in EDTRS letters. Group means were 4.1, 4.3, and 4.4 for 0.3%, 0.1%, and placebo, respectively. The unadjusted mean differences versus placebo were -0.3 and -0.1, with intervals spanning zero and values in both directions.

The registry states that the primary analysis used a Bayesian approach, but numerical posterior results and key analysis details are not reported. Secondary results are incomplete, and zero serious adverse events and zero deaths were reported in each group. The record does not report the original sample-size justification, missing-data methods, or multiplicity plan.