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 Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 (NCT05470881), a na phase 1 study. The primary outcome is Number of Unexpected Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05470881 |
| Phase | Phase 1 |
| Condition | Myopia |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Laboratorios Sophia S.A de C.V. |
| Results posted | Yes |
2. Clinical Question
Population
The study planned to expose 29 healthy volunteers to the investigation product, and the registry record lists 29 participants at risk for adverse events. Myopia is listed as a condition, but the stated study population is healthy volunteers. Further eligibility details are not reported in the registry record.
Intervention
The intervention was PRO-201, identified in the study description as 0.01% sulfate atropine and in the intervention record as atropine sulfate. It was applied to the ocular surface. The dosing schedule and duration of administration are not reported in the registry record.
Comparator
There was no separate comparator group recorded. The study is described as a single-group trial, with allocation listed as not applicable and masking listed as none. The registry record therefore does not provide a concurrent control group for comparison.
Primary question
The primary question was how many unexpected adverse events occurred during the trial through Day 21 ± 1, including the safety call. The endpoint defined unexpected events as events not previously described or known for the active substance in this pharmaceutical form and concentration. Its numerical result is not reported in the registry record.
3. Trial Design
This was a Phase I clinical study of PRO-201 ophthalmic solution, registered as NCT05470881. The registry record describes a single-group design and lists no allocation and no masking. A total of 29 participants were planned for exposure, and 29 were recorded as at risk in the adverse-event information. The study is marked completed.
The listed population was healthy volunteers, while the registry record also lists myopia as a condition. The record does not explain the relationship between that condition listing and the healthy-volunteer description. Further eligibility criteria, recruitment procedures, and participant characteristics are not reported in the registry record.
The intervention is identified as atropine sulfate and described as PRO-201 (0.01% sulfate atropine). The record says it was applied to the ocular surface. Administration details, including the number and timing of instillations, are not reported in the registry record.
The registry identifies unexpected adverse events and photophobia as primary outcome variables in the brief study description. The formal primary outcome record is titled “Number of Unexpected Adverse Events,” uses adverse events as its unit, and specifies follow-up through Day 21 ± 1 (Safety Call). The brief description also lists assessments including pupil diameter, expected adverse events, visual acuity, intraocular pressure, ocular staining, cardiovascular measures, and ocular comfort.
Because the study has no recorded comparator group, it describes observations following exposure rather than a randomized comparison of treatments. The allocation method beyond “not applicable,” the rationale for the design, and any protocol-level explanation of the sample size are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | PRO-201 |
|---|---|
| STARTED | 29 |
| COMPLETED | 27 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | PRO-201 |
|---|---|
| Adherence under 90% | 2 |
Analysis population for the primary outcome, as defined in the registry: The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
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: The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
| Characteristic | Unit | PRO-201 |
|---|---|---|
| Participants analysed | 29 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 29 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 22.033 (SD 3.61) |
| Sex: Female, Male: Female | Participants | 19 |
| Sex: Female, Male: Male | Participants | 10 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: Mexico | participants | 29 |
| Intraocular pressure (IOP) | mmhg | 14.67 (SD 2.67) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Unexpected Adverse Events, measured over Through Day 21 ± 1 (Safety Call).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | adverse events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of unexpected adverse events through Day 21 ± 1, including the safety call. The registry defines these as adverse events not previously described or known for the active substance in this pharmaceutical form and concentration. The endpoint is recorded as a count of events, rather than a change from baseline or a comparison between treatment groups.
Safety monitoring is a central purpose of an early-phase study. A count of unexpected events can help describe whether observations arose that were not already characterized for the substance and formulation. The registry’s brief description also names photophobia as a primary outcome variable, but the formal primary outcome entry gives the unexpected-adverse-event count. The relationship between these descriptions is not explained in the registry record.
A count should not automatically be interpreted as the number of participants affected: one participant may experience more than one event, and a participant count and an event count answer different questions. The registry record does not report the numerical result for this primary endpoint, the event-level descriptions, or a statistical estimate of its uncertainty. The observed count therefore cannot be characterized from the primary outcome record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes the study’s design and intended safety question, but it does not report a numerical result for the primary endpoint. The outcome was the number of unexpected adverse events through Day 21 ± 1 (Safety Call). Without that endpoint result, the occurrence or frequency of unexpected events under the study’s definition cannot be summarized from the registry record.
The adverse-event information reports 0 serious adverse events among 29 participants at risk and 21 participants with other adverse events among 29 at risk. These figures are separate from the primary endpoint: the record does not identify the 21 participants’ events as unexpected, and it does not provide event-level descriptions in the adverse-event summary. The serious-event count alone does not describe all adverse events.
The registry record lists 11 outcome measures and 0 analyses. It names several assessments in the brief description, including photophobia, pupil diameter, visual acuity, intraocular pressure, ocular staining, heart rate, blood pressure, and ocular comfort. Numerical results for these measures are not reported in the registry record. Their measurement schedules, analytic summaries, and uncertainty estimates are also not reported in the registry record.
With a single group and no recorded comparator, the findings would describe observations among participants exposed to PRO-201; the design does not provide a concurrent untreated or alternative-treatment estimate. General statistical interpretation: an observed count in a single group can describe what was recorded under the study’s monitoring and follow-up, but it cannot by itself separate the effects of exposure from other explanations or estimate a comparative treatment effect.
No confidence interval, hypothesis test, or adjusted estimate is reported in the registry record. General statistical interpretation: a confidence interval communicates the precision of an estimate under the assumptions of the analysis; without a reported estimate and interval, the precision of the primary safety result cannot be assessed. The absence of an analysis entry also means the registry record does not document how the outcomes were statistically analyzed.
The completed status and recorded participant count do not fill in these missing results. The record supports a description of the study setup and the adverse-event summary figures, but not a quantitative conclusion about the primary endpoint or the other listed measurements.
9. Statistical Methods Explained
The registry describes a single-group Phase I study with 29 participants recorded as at risk for adverse events. Allocation is listed as not applicable and masking as none. The posted record contains 0 analyses. It does not report a statistical analysis plan, model, confidence intervals, hypothesis tests, or the method used to summarize the primary endpoint. The explanations below are general statistical context, not descriptions of methods confirmed to have been used in this study.
What a single-group design can describe
General: In a single-group study, outcome observations are collected in one group rather than contrasted with a concurrently assigned control group. This can describe what was observed during the study’s follow-up and under its procedures. It does not, on its own, establish what would have happened to the same participants without the intervention. Differences due to participants’ characteristics, concurrent events, or the way outcomes are observed cannot be separated through a randomized between-group comparison when no comparator group is recorded.
For this trial, the registry identifies exposure to PRO-201 and a safety follow-up period through Day 21 ± 1 for the primary outcome. It does not report a comparator, a baseline-adjusted analysis, or a method for accounting for other influences on observations. Those features should not be assumed.
Counts and event definitions
General: A count records how many events meet a defined rule. The event definition matters: changing what qualifies as an event, or how events are classified, can change the count. A count of events is also distinct from a count of participants with at least one event. One participant can have multiple events, so these quantities are not interchangeable.
The primary outcome is titled “Number of Unexpected Adverse Events,” and the registry describes unexpected events as those not previously described or known for the active substance in this formulation and concentration. The registry does not report the resulting count or event-level classifications. The adverse-event summary’s figure for participants with other adverse events should not be substituted for the primary endpoint, because the summary does not establish that those events were unexpected or give the number of unexpected events.
Precision and uncertainty
General: An estimate is more informative when its uncertainty is also described. A confidence interval gives a range of values compatible with the observed data under a specified statistical procedure and its assumptions. For counts, suitable approaches can depend on the event process, follow-up, and whether events are independent. When events vary more than a simple probability model expects, over-dispersion can make a basic model’s uncertainty too small. That is a general consideration, not a finding about this study.
The registry record does not provide an interval, a model, or details sufficient to assess the assumptions behind an uncertainty calculation. No precision estimate for the primary endpoint is therefore reported in the registry record. It would be inappropriate to infer one from the adverse-event summary alone.
Comparative tests and effect estimates
General: A comparative treatment effect requires a defined contrast, such as a difference between groups or a within-person change over specified measurements. A test statistic or p-value addresses a particular statistical hypothesis under a model; it does not replace an effect estimate or communicate its practical importance. In a study without a recorded comparator group, a treatment-versus-control contrast is not available from the design description.
The registry does not report p-values, comparative estimates, or a test plan. No claim about statistical significance can be made from the posted results. The record’s lack of an analysis entry should not be filled by assuming a standard test.
Planning calculations and observed results
General: Sample-size planning is based on assumptions about the outcome, target effect, variability, significance level, and desired power. A planning illustration is not an observed result and does not show the probability that a completed study detected an effect. The registry record states that its planning illustration uses an observed effect and specified assumptions, but it does not document that illustration as the trial’s original design justification. A trial-specific sample-size rationale is not reported in the registry record.
The number of participants enrolled or recorded at risk describes the study size; it does not establish statistical power. No observed-power result is reported in the registry record. With no numerical primary outcome, analysis, or uncertainty estimate posted, the available information is insufficient to reconstruct the study’s inferential results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 11 outcome measures and 0 analyses. The brief description identifies unexpected adverse events and photophobia as primary outcome variables and lists additional safety and ocular measurements. The formal primary outcome entry specifies the number of unexpected adverse events. Three secondary outcomes are listed: pupil diameter, percentage of expected adverse events, and change in best near corrected visual acuity. The record does not explain how the formal primary entry relates to the brief description’s mention of photophobia as a primary variable.
Multiplicity arises when several outcomes or statistical tests are considered: the chance of at least one apparently notable result can increase when many tests are performed. General statistical practice may address this by prespecifying a primary outcome, defining a testing hierarchy, or adjusting interpretation for multiple comparisons. The registry record does not report a multiplicity procedure, a testing hierarchy, or an analysis plan. It is therefore not possible to determine how multiple outcomes were handled.
Missing-data methods and analysis populations are not reported in the registry record. The record does not state how missing measurements, missed visits, withdrawals, or incomplete follow-up were handled, nor does it identify a safety or efficacy analysis population. The adverse-event summary lists 29 participants at risk, but that figure does not establish the completeness of every outcome assessment. The registry record also does not report the number of participants with missing data for each measure.
These omissions limit assessment of whether the posted summaries represent all enrolled participants and whether outcome comparisons were planned in advance. No assumption about imputation, exclusions, or protocol deviations can be made from 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 |
|---|---|---|---|
| PRO-201 | 0 | 29 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PRO-201 | 0 of 29 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PRO-201 | 21 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PRO-201 |
|---|---|---|
| irritation in the area of instillation | Eye disorders | 10 of 29 |
| Burning sensation | Eye disorders | 9 of 29 |
| Blurred vision | Eye disorders | 7 of 29 |
| Ocular hyperemia | Eye disorders | 4 of 29 |
| Pruritus | Eye disorders | 3 of 29 |
| Tearing | Eye disorders | 3 of 29 |
| Foreign body sensation | Eye disorders | 2 of 29 |
| Headache | Nervous system disorders | 2 of 29 |
| decreased visual acuity | Eye disorders | 2 of 29 |
The adverse-event summary records 29 participants at risk, 0 serious adverse events, 0 deaths, and 21 participants with other adverse events. These categories should be kept distinct. The serious-event figure is not a count of all adverse events, and the other-adverse-event figure does not show how many events occurred or whether those events met the primary endpoint’s definition of unexpected.
The primary outcome is a count of unexpected adverse events through Day 21 ± 1 (Safety Call). The registry’s adverse-event summary does not provide the numerical result for that endpoint. It also does not include serious adverse-event terms in the listed summary. Thus, the figures for serious and other adverse events do not allow the primary count to be reconstructed.
General: A zero recorded count means that no event in that category is reported in the registry summary; it does not prove that an event is impossible or that every potential harm has been ruled out. Interpretation also depends on the size and characteristics of the group, follow-up, ascertainment, and reporting. Further details about event timing, severity, relatedness, and participant-level recurrence are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record identifies a completed Phase I, single-group study of PRO-201 in healthy volunteers and defines a safety endpoint: the number of unexpected adverse events through Day 21 ± 1. It also reports 0 serious adverse events and 21 participants with other adverse events among 29 at risk. These are the posted safety figures that can be stated directly.
The numerical result for the primary endpoint is not reported in the registry record. Nor are numerical results reported for the listed measurements of photophobia, pupil diameter, visual acuity, intraocular pressure, ocular staining, heart rate, blood pressure, and ocular comfort. The record does not provide statistical estimates or confidence intervals for these outcomes. Their magnitude and precision therefore cannot be assessed from the posted results.
The adverse-event summary does not show whether other events were unexpected, and its participant figure is not equivalent to a count of events. It cannot be used as a substitute for the primary endpoint. The registry also does not report enough detail to evaluate how event classification, missing measurements, or analysis-population decisions may have affected the results.
General: A single-group safety study can describe what was recorded among exposed participants during the study’s observation period. It does not provide a randomized comparison with another treatment or no treatment. Accordingly, the design description alone cannot establish a comparative effect or attribute every observed event to the intervention. These are limits on what the record can establish, not conclusions about the intervention’s effects.
The completed status indicates that the study is marked complete in the registry. It does not itself supply the missing endpoint results or statistical analysis. The record therefore supports a description of the study and its posted adverse-event summary, but leaves the primary safety result and the precision of the other outcomes undetermined.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the difference between a registered question and a reported result. The record specifies a primary safety endpoint and a follow-up window, yet the numerical primary endpoint result is not reported in the registry record. Without that result, readers cannot characterize the observed count or its uncertainty.
The study also illustrates why event counts and participant counts should not be conflated. Its primary endpoint is a number of unexpected adverse events, while the adverse-event summary reports participants with serious or other events. Those measures have different meanings, and the posted summary does not link the other-event figure to the unexpected-event definition.
The single-group design is another important statistical feature. It can describe observed outcomes after exposure, but it does not create a concurrent randomized contrast. Readers should distinguish descriptive safety information from evidence that would require a comparator to estimate a treatment difference. The record lists no analyses, and it does not report inferential estimates or a statistical plan.
Finally, the study description names several outcomes, while the formal primary entry identifies the unexpected-event count. The registry does not explain the relationship between that entry and photophobia, which the brief summary also calls a primary variable. Clear outcome definitions and transparent reporting of analysis choices matter because they help readers understand which questions were prioritized and how results should be interpreted.
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 statistical interpretation is that the numerical result for the formal primary endpoint is not reported in the registry record. The record also lists 0 analyses and does not report confidence intervals, hypothesis tests, or an analysis plan. This prevents assessment of the estimated event count and its precision.
The single-group design has no recorded comparator, so it cannot provide a randomized between-group contrast. Masking is listed as none. The registry does not report how outcome ascertainment was standardized or whether any additional safeguards were used to limit measurement or classification bias.
The primary endpoint concerns unexpected events, but the adverse-event summary does not identify which reported events were unexpected. Event-level descriptions and the numerical primary outcome are not reported in the registry record. The summary’s count of participants with other adverse events cannot be treated as the primary event count.
The registry names multiple safety and ocular outcomes but does not report numerical results for them. It also does not report a multiplicity strategy, missing-data methods, analysis populations, participant characteristics, or the handling of incomplete follow-up. The relationship between the formal primary outcome and the brief description’s mention of photophobia as a primary variable is not explained.
Finally, the record does not report a trial-specific sample-size justification. These limitations describe gaps in the registry record and constraints of the design; they do not establish what unreported analyses or procedures may have been conducted elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 — NCT05470881.
- Registry record last updated 2026-02-05; status last verified 2026-02.
- Results first posted 2026-02-05.
- 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
NCT05470881 is a completed Phase I, single-group study of PRO-201 ophthalmic solution, identified as 0.01% sulfate atropine, in healthy volunteers. The registry lists 29 participants planned for exposure and 29 at risk in the adverse-event summary. Allocation is listed as not applicable, and masking as none.
The formal primary outcome is the number of unexpected adverse events through Day 21 ± 1 (Safety Call). Its numerical result is not reported in the registry record. The adverse-event summary reports 0 serious adverse events, 0 deaths, and 21 participants with other adverse events among 29 at risk. The record lists 11 outcome measures and 0 analyses.
Statistical analysis methods, uncertainty estimates, missing-data handling, analysis populations, and a trial-specific sample-size justification are not reported in the registry record.