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 Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) (NCT02980523), a randomized phase 2 study. The primary outcome is Change From Baseline Bacterial Culture.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02980523 |
| Phase | Phase 2 |
| Condition | Bacterial Conjunctivitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 150 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Laboratorios Sophia S.A de C.V. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with bacterial conjunctivitis were eligible for the trial. The registry record describes cultures from the lower conjunctival pouch and says the treatment analysis used a culture per eye. Its brief summary says 300 eyes, with 60 per group; arm descriptions specify 60 eyes of 30 research subjects in each group. The registry enrollment is recorded as 150. The record does not explain how these enrollment descriptions relate to one another.
Intervention
The intervention was PRO-157, identified in the arm descriptions as pazufloxacin, tested in three dosing schedules: one drop two times daily, three times daily, or four times daily. Each regimen was described as lasting 7 days. Lagricel Ofteno®, identified as sodium hyaluronate 0.4%, was also used in the arm descriptions. The record describes administration in both eyes.
Comparator
The comparator groups received moxifloxacin or gatifloxacin, each described as one drop three times daily for 7 days. The listed brand names are Vigamox® for moxifloxacin and Zymar® for gatifloxacin. Lagricel Ofteno® was also part of the described regimens. The trial therefore included five treatment groups, rather than a single comparison between PRO-157 and one comparator.
Primary question
The primary question was whether bacterial cultures changed between baseline and the final visit after treatment. Cultures were collected at baseline on day 1 and at the final visit on day 8. The registry describes quantifying and identifying colony-forming units by genus and species, and considering eradication, reduction, or proliferation of the bacterial agent. It defines effectiveness as a reduction in bacterial flora in at least 95% of evaluated subjects. The registry record does not report the observed culture results or a statistical comparison among the groups.
3. Trial Design
The registry describes NCT02980523 as a randomized, double-blind, parallel-group, phase II, multicenter trial. Its stated objective was to evaluate the safety and efficacy of PRO-157 ophthalmic solution at three dosing frequencies against moxifloxacin and gatifloxacin in patients with bacterial conjunctivitis. The sponsor is Laboratorios Sophia S.A de C.V. The recorded start was 2015-03, primary completion was 2016-06, and status is completed.
The five groups were PRO-157 two times daily, PRO-157 three times daily, PRO-157 four times daily, moxifloxacin three times daily, and gatifloxacin three times daily. Each antibiotic regimen was described as lasting 7 days. The arm descriptions also include Lagricel Ofteno®, sodium hyaluronate 0.4%. Medication and study procedures were described as being applied to both eyes, while the infected eye or eyes were identified at baseline for protocol purposes.
The planned evaluations included baseline on day 1, a visit on day 3, a final visit on day 8, and a telephone call on day 23 for adverse-event evaluation. The main efficacy criterion was based on comparing bacterial cultures from baseline and the final visit. The brief summary also describes clinical evaluation through signs and symptoms, and identifies visual acuity and adverse events as safety measurements. Listed secondary outcomes include ocular secretion, conjunctival hyperemia, chemosis, eyelid edema, and corneal epithelial defects.
The registry enrollment is recorded as 150. The brief summary describes 300 eyes and 60 per group, while each arm description states 60 eyes of 30 research subjects. The record does not reconcile these descriptions. Further details of randomization, allocation concealment, masking procedures, or site-level conduct 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-157 BID (2 Times Per Day) | PRO-157 TID (3 Times Per Day) | PRO-157 QID (4 Times Per Day) | Moxifloxacin (Vigamox®) | Gatifloxacin (Zymar®) |
|---|---|---|---|---|---|
| STARTED | 30 | 30 | 30 | 30 | 30 |
| COMPLETED | 27 | 19 | 24 | 21 | 20 |
| NOT COMPLETED | 3 | 11 | 6 | 9 | 10 |
Reasons for not completing this period:
| Reason | PRO-157 BID (2 Times Per Day) | PRO-157 TID (3 Times Per Day) | PRO-157 QID (4 Times Per Day) | Moxifloxacin (Vigamox®) | Gatifloxacin (Zymar®) |
|---|---|---|---|---|---|
| Lost to Follow-up | 1 | 4 | 1 | 2 | 1 |
| Excluded from analysis | 1 | 3 | 1 | 1 | 1 |
| Lack of Efficacy | 1 | 4 | 4 | 5 | 8 |
| Did not receive intervention | 0 | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Treatment analysis, a culture was performed per eye
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 | PRO-157 BID | PRO-157 TID | PRO-157 QID | Moxifloxacine | Gatifloxacine | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 27 | 19 | 24 | 21 | 20 | 111 | |
| Age, Categorical: <=18 years | Participants | 7 | 3 | 7 | 5 | 5 | 27 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 | 13 | 10 | 11 | 8 | 53 |
| Age, Categorical: >=65 years | Participants | 9 | 3 | 7 | 5 | 7 | 31 |
| Age, Continuous | years | 41.1 (SD 27.9) | 37.2 (SD 21.3) | 43.3 (SD 25.7) | 39.9 (SD 26.9) | 43.4 (SD 29.5) | 40.8 (SD 26.2) |
| Sex: Female, Male: Female | Participants | 19 | 10 | 16 | 13 | 11 | 69 |
| Sex: Female, Male: Male | Participants | 8 | 9 | 8 | 8 | 9 | 42 |
| Region of Enrollment: Mexico – Mexicans | Participants | 27 | 19 | 24 | 21 | 20 | 111 |
| Region of Enrollment: Mexico – others | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline Bacterial Culture, measured over up to one week.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | cultures |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in bacterial culture from baseline to the final visit. The registry describes collecting cultures from the lower conjunctival pouch on day 1 and day 8, then quantifying colony-forming units and identifying bacteria by genus and species. This makes the endpoint a microbiological measure: it tracks whether the detected bacterial flora are eradicated, reduced, or proliferate over the treatment period.
Culture measurements can convey information about bacterial burden and identity that is distinct from a clinical assessment of signs and symptoms. Those clinical features were also part of the trial’s evaluation, but the primary endpoint is defined through culture results. The registry describes the measurement as discrete quantitative data, with colony-forming units per milliliter as the scale. It states that effectiveness would be determined by a reduction in bacterial flora in at least 95% of evaluated subjects. This is the stated criterion, not a reported finding.
The endpoint needs interpretation alongside its analysis unit. The record says a culture was performed per eye for the treatment analysis, and arm descriptions state that both eyes were treated. Eyes from the same person may have correlated measurements; as a general statistical matter, an analysis should account for such within-person dependence if both eyes contribute. The registry record does not describe how that dependence was handled, nor does it report group-level culture changes, uncertainty intervals, or statistical tests. Consequently, the endpoint definition is available, but its observed results and comparative precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes what the trial set out to compare and how its primary microbiological outcome was defined. It does not report the baseline and final culture values, the number of participants meeting the stated efficacy criterion, or the estimated differences between treatment groups. Without those results, the relative culture outcomes of the PRO-157 schedules, moxifloxacin, and gatifloxacin cannot be assessed from the registry record.
The stated primary criterion is a reduction in bacterial flora in at least 95% of evaluated subjects. That criterion describes the threshold used to define effectiveness in the registry summary; it is not evidence that the threshold was achieved. No group-specific proportions, confidence intervals, or hypothesis-test results for this endpoint are reported in the registry record. The record also does not provide enough detail to determine whether the primary analysis treated culture change as a count, a category, or both, or how it handled differing bacterial species and starting levels.
The treatment structure matters. There were three PRO-157 schedules and two active comparator regimens. A result for one schedule would not automatically establish the result for another schedule, and a comparison with one comparator would not answer every possible comparison in this five-group trial. The registry record does not identify a single contrast as the principal statistical comparison or report adjustments for multiple comparisons. No conclusion about comparative efficacy should be inferred from the design alone.
Safety reporting is more concrete, but remains descriptive. The registry lists serious adverse events affecting 0 participants in each PRO-157 group and 1 participant in each comparator group. It also lists other adverse events affecting 7, 5, 7, 3, and 6 participants, respectively, across the PRO-157 two-times-daily, PRO-157 three-times-daily, PRO-157 four-times-daily, moxifloxacin, and gatifloxacin groups. The record does not report statistical comparisons for these counts. Small group counts and a limited observation period mean that the listing should not be read as a precise estimate of uncommon harms.
The named serious adverse-event terms are urinary tract infection (ITU) and ischemic optic neuropathy, each listed at 3.3%. The record does not associate those terms with specific treatment groups in the information available for interpretation, so they should not be assigned to a group. Deaths are not reported in the registry record. In general, adverse-event counts describe events recorded during the trial; they do not by themselves establish whether an event was caused by a treatment.
Overall, the completed-trial status and stated outcome definitions do not substitute for posted efficacy results. The available record supports a description of the study design and selected adverse-event counts, but it does not support a statistical judgment about which regimen produced greater bacterial-culture improvement or whether observed differences were compatible with chance.
9. Statistical Methods Explained
Statistical interpretation begins with the outcome and the unit being analyzed. Here, the primary outcome concerns bacterial culture at baseline and at the final visit. The record describes colony-forming units and bacterial identification by genus and species, and says cultures were taken per eye for the treatment analysis. That makes it important to know whether results were summarized as raw counts, change from baseline, presence or absence of particular bacteria, or a categorical response. The registry record does not report the detailed analysis method or the results for any of these possible representations.
Why can culture counts need special treatment?
General statistical explanation: counts are nonnegative discrete measurements. Their distribution can be strongly right-skewed, especially if many observations are low and a few are much larger. Methods designed for normally distributed measurements may then describe the data poorly. A count model can be appropriate when its assumptions match the data and study design. Some count models assume that the variability follows a specific relationship to the mean. If the observed variability is greater than that assumption allows, the data are over-dispersed. General methods can account for over-dispersion, but the suitable approach depends on the actual distribution, analysis unit, and estimand.
The registry labels the variable discrete quantitative and gives colony-forming units per milliliter as the measurement scale. That description alone does not establish which model was used. The statistical analysis plan, transformations, handling of zero counts, and any model for bacterial species are not reported in the registry record. It is therefore not possible to determine from the record whether the analysis used an approach suited to the observed distribution or how changes across species were combined.
Why does the eye-level measurement matter?
General statistical explanation: two eyes from one person are not necessarily independent observations. They share characteristics of the same person and may share exposure, care, and disease-related factors. If both eyes contribute data, analyses that treat every eye as wholly independent can make uncertainty appear smaller than it is. Methods such as clustered standard errors, multilevel models, or a prespecified approach selecting one eye can address dependence in different ways. These are general options, not claims about what this trial did.
The registry describes both-eye treatment and a culture per eye in the treatment analysis, while arm descriptions give 60 eyes of 30 research subjects in each group. The analysis population and any handling of within-person correlation are not described in further detail. This limits interpretation of the effective amount of independent information in the culture analysis. It also makes it important to distinguish an eye-level denominator from a participant-level denominator when reading any result.
What does a confidence interval tell a reader?
General statistical explanation: a confidence interval gives a range of values compatible with the observed data under the statistical model and its assumptions. A narrower interval indicates greater precision for the estimate; a wider interval indicates greater uncertainty. For a comparison, an interval can show whether the data are consistent with effects in more than one direction or with little difference. The registry record does not report confidence intervals for the primary endpoint or treatment comparisons, so the precision of any efficacy estimate cannot be assessed.
A p-value, when reported, summarizes how surprising data at least as extreme as those observed would be under a specified null hypothesis and model. It is not the probability that a treatment is effective, nor does it measure the size or clinical importance of an effect. The registry record does not report primary-outcome p-values or identify the hypotheses used for the group comparisons. No inference about statistical significance can be made from the adverse-event counts alone.
How should multiple groups and outcomes be considered?
General statistical explanation: testing several treatment contrasts or endpoints creates multiple opportunities to observe an apparently unusual result by chance. A prespecified primary comparison, a multiplicity adjustment, or a hierarchical testing strategy can help control the interpretation of a family of tests. Each approach answers a different question and depends on choices made in the protocol or analysis plan. The registry record does not report a prespecified contrast, a multiplicity strategy, or the handling of secondary-outcome tests.
The record describes five treatment groups and lists a primary culture outcome alongside clinical and safety measures. Several secondary outcomes concern signs of conjunctivitis, including ocular secretion, conjunctival hyperemia, chemosis, eyelid edema, and corneal epithelial defects. The registry counts 7 outcome measures and 7 analyses, but does not provide enough information to map each analysis to its exact outcome, time point, or contrast. The results cannot therefore be interpreted as a complete family of prespecified tests.
What do planning calculations mean?
General statistical explanation: sample-size calculations are planning exercises based on assumptions about the effect to detect, variability, allocation, significance level, and statistical method. They do not describe the strength of evidence observed after a trial is complete. The planning illustration associated with this trial is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. For time-to-event calculations, the stated output is a total event count; for other calculations, it is participants per arm. The numerical planning outputs and selected comparisons are not reported in the registry record. Such calculations are not observed power, and they cannot fill the gap left by missing outcome estimates.
Randomization and double masking are design features intended to reduce systematic differences and bias, but their labels do not reveal the details of implementation. The randomization sequence, concealment procedures, masking assessment, analysis model, missing-data method, and analysis populations beyond the stated treatment analysis are not reported in the registry record. Statistical confidence in a treatment comparison depends on these details as well as on the outcome estimates themselves. Without the full results and methods, interpretation should remain descriptive.
10. Multiplicity, Missing Data and Analysis Populations
The trial has several potential sources of multiplicity: five treatment groups, a culture-based primary endpoint, and multiple clinical and safety measures. The record lists five secondary outcomes: frequency of ocular secretion, cases of conjunctival hyperemia, chemosis frequency, eyelid edema frequency, and frequency of corneal epithelial defects. It also records 7 outcome measures and 7 analyses. However, it does not report which contrasts were prespecified, how outcome time points were selected, or whether statistical tests were adjusted for multiple comparisons. Those elements are not reported in the registry record.
General statistical explanation: when many comparisons are made, the chance of at least one apparently notable result can increase. A prespecified testing hierarchy or adjustment can help limit that risk. In the absence of a reported strategy, separate results should not be treated as though they were the sole planned test. Since the primary efficacy results and comparison tests are not reported, multiplicity cannot be evaluated for the actual findings.
Missing-data handling is also not described. The record does not report how participants or eyes without a final culture were handled, whether any observations were excluded, or whether sensitivity analyses were performed. It does not describe missingness for the clinical measures or adverse-event follow-up. The visit schedule included a day 23 telephone call for adverse-event evaluation, but completeness of follow-up is not reported.
The primary endpoint description identifies a treatment analysis and says a culture was performed per eye. Other analysis populations, such as an intention-to-treat population, are not reported in the registry record. It is also not clear whether the analysis preserved the randomized group assignment for all observations or how deviations from the dosing regimen were handled. These omissions limit assessment of potential bias and the robustness of any estimated treatment effect.
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-157 BID (2 Times Per Day) | 0 | 30 | 0.0% |
| PRO-157 TID (3 Times Per Day) | 0 | 30 | 0.0% |
| PRO-157 QID (4 Times Per Day) | 0 | 30 | 0.0% |
| Moxifloxacin (Vigamox®) | 1 | 30 | 3.3% |
| Gatifloxacin (Zymar®) | 1 | 30 | 3.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PRO-157 BID (2 Times Per Day) | 7 of 30 |
| PRO-157 TID (3 Times Per Day) | 5 of 30 |
| PRO-157 QID (4 Times Per Day) | 7 of 30 |
| Moxifloxacin (Vigamox®) | 3 of 30 |
| Gatifloxacin (Zymar®) | 6 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | PRO-157 BID (2 Times Per Day) | PRO-157 TID (3 Times Per Day) | PRO-157 QID (4 Times Per Day) | Moxifloxacin (Vigamox®) | Gatifloxacin (Zymar®) |
|---|---|---|---|---|---|---|
| urinary tract infection (ITU) | Renal and urinary disorders | 0 of 30 | 0 of 30 | 0 of 30 | 1 of 30 | 0 of 30 |
| ischemic optic neuropathy | Eye disorders | 0 of 30 | 0 of 30 | 0 of 30 | 0 of 30 | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PRO-157 BID (2 Times Per Day) | PRO-157 TID (3 Times Per Day) | PRO-157 QID (4 Times Per Day) | Moxifloxacin (Vigamox®) | Gatifloxacin (Zymar®) |
|---|---|---|---|---|---|---|
| Numular keratitis | Eye disorders | 2 of 30 | 0 of 30 | 0 of 30 | 0 of 30 | 2 of 30 |
| Lack of effectiveness | General disorders | 0 of 30 | 0 of 30 | 3 of 30 | 0 of 30 | 1 of 30 |
| Dysgeusia | Gastrointestinal disorders | 1 of 30 | 0 of 30 | 1 of 30 | 1 of 30 | 0 of 30 |
| Headache | Nervous system disorders | 1 of 30 | 1 of 30 | 1 of 30 | 0 of 30 | 0 of 30 |
| Tinnitus | Ear and labyrinth disorders | 0 of 30 | 1 of 30 | 0 of 30 | 0 of 30 | 1 of 30 |
| Eyelid ecchymosis | Eye disorders | 0 of 30 | 1 of 30 | 0 of 30 | 0 of 30 | 0 of 30 |
| stomach flu | Gastrointestinal disorders | 0 of 30 | 1 of 30 | 0 of 30 | 0 of 30 | 0 of 30 |
| hordeolum | Eye disorders | 0 of 30 | 0 of 30 | 1 of 30 | 0 of 30 | 0 of 30 |
| eye pain | Eye disorders | 1 of 30 | 0 of 30 | 0 of 30 | 0 of 30 | 0 of 30 |
| dizziness | Nervous system disorders | 1 of 30 | 0 of 30 | 0 of 30 | 0 of 30 | 0 of 30 |
Serious events with the highest arm-level rate: urinary tract infection (itu) (3.3%), ischemic optic neuropathy (3.3%).
The adverse-event listing reports serious events separately from other adverse events. For serious events, the registry lists 0 affected participants in each of the three PRO-157 groups and 1 affected participant in each of the moxifloxacin and gatifloxacin groups. The number at risk is recorded as 30 in each group. These are descriptive counts; the registry record does not report statistical comparisons or uncertainty intervals for them.
For other adverse events, the listed affected-participant counts are 7 for PRO-157 two times daily, 5 for PRO-157 three times daily, 7 for PRO-157 four times daily, 3 for moxifloxacin, and 6 for gatifloxacin. These counts should not be interpreted as comparative rates beyond the groups and denominators recorded, and the record does not describe whether events were recurrent or how event severity was classified for this category.
The serious-event terms listed are urinary tract infection (ITU) at 3.3% and ischemic optic neuropathy at 3.3%. The record does not link these terms to particular groups in the information available for interpretation. Deaths are not reported in the registry record. General statistical explanation: rare events are difficult to characterize precisely in small groups, and a count of zero does not establish that an event cannot occur. Event counts also do not establish causation. The registry record does not provide enough detail to assess relatedness, timing, or comparative risk.
12. What the Result Does, and Does Not, Mean
The trial record supports a clear description of the study question: a randomized, double-blind, phase II comparison of three PRO-157 dosing schedules with moxifloxacin and gatifloxacin in bacterial conjunctivitis. The primary culture endpoint was defined by comparing baseline and final cultures, quantifying colony-forming units, identifying bacterial genus and species, and considering eradication, reduction, or proliferation. The record also describes a criterion for effectiveness based on reduction of bacterial flora in at least 95% of evaluated subjects.
Those definitions do not show whether the criterion was met. The registry record does not report the primary culture results, the proportion meeting the criterion, the treatment-group estimates, or uncertainty around comparisons. It therefore does not establish whether one regimen had more or less culture change than another, or how precise such a comparison might be. The stated design and completed status cannot be used as substitutes for efficacy results.
The safety listing reports serious and other adverse-event counts by group, along with two serious-event terms and their listed percentages. These data describe what was recorded in the registry; they do not establish that a treatment caused an event or provide a precise comparison of risk. Deaths and additional details about adverse-event timing, relatedness, and follow-up are not reported in the registry record.
General statistical explanation: a treatment comparison is most informative when the effect estimate, its uncertainty, the analysis population, and the methods are all available. A small p-value alone would not establish clinical importance, and a non-significant result would not prove equivalence. In this case, the registry record does not report the primary comparison results or a statistical plan, so neither conclusion can be drawn. The appropriate interpretation is limited to the trial’s design, outcome definitions, and descriptive safety information actually recorded.
13. Why This Trial Matters Statistically
This trial illustrates why a treatment study’s endpoint definition and its reported results are both necessary for statistical interpretation. The primary endpoint is microbiological, using cultures from the lower conjunctival pouch at baseline and the final visit. It is not interchangeable with clinical signs or symptoms, which were separately considered in the trial. A culture-based outcome can be useful for assessing changes in detected bacterial flora, but its interpretation depends on how colony counts, species, and paired measurements are analyzed.
The five-group design also makes the comparison question important. PRO-157 was tested at three dosing frequencies, alongside two comparator regimens. These groups can support different questions, but the registry record does not identify one primary contrast or report the results needed to compare them. Without a stated comparison strategy, readers should avoid treating one possible pairwise contrast as the whole trial question.
The record’s descriptions of enrollment and eye-level measurement also highlight the need to distinguish people from eyes. It records enrollment of 150, describes 300 eyes and 60 per group in the brief summary, and describes 60 eyes of 30 research subjects in each arm. Since the treatment analysis is described as using a culture per eye, the statistical treatment of correlation between eyes is relevant. The registry record does not explain that handling.
Finally, the available adverse-event counts show why safety interpretation needs context and precision estimates, not just group counts. Counts in small groups can be informative as a descriptive record while remaining insufficient to establish comparative risk. The missing primary results, analysis details, and multiplicity information leave important statistical questions unanswered. The trial is therefore useful as an example of how registry design and outcome definitions can be available even when the evidence needed for an efficacy comparison is not reported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation is that the registry record does not report the primary efficacy results. There are no group-specific baseline or final culture measurements, changes in colony-forming units, proportions meeting the stated effectiveness criterion, or comparative estimates. Confidence intervals and primary-outcome test results are also not reported. This prevents evaluation of both the direction and precision of the culture findings.
The record does not explain the statistical analysis in enough detail to assess how it handled quantitative culture counts, bacterial species, or measurements from both eyes. Although the treatment analysis is described as having a culture per eye, the method for accounting for within-person dependence is not reported. The enrollment descriptions differ in unit and presentation: registry enrollment is 150, the brief summary describes 300 eyes and 60 per group, and each arm description states 60 eyes of 30 research subjects. The record does not reconcile these descriptions.
Further limitations include the absence of reported details about allocation concealment, the analysis populations, missing-data handling, protocol deviations, and prespecified statistical comparisons. A multiplicity approach for the five treatment groups and several outcomes is not reported. The record lists safety counts, but does not provide uncertainty intervals, event timing, relatedness, or details sufficient to assess comparative risks. Deaths are not reported in the registry record.
The registry identifies the study as completed and provides a visit schedule, but completeness of follow-up and adherence to the scheduled evaluations are not reported. These gaps do not prove that the conduct or analyses were inadequate; they mean that the information needed to assess those features is not available in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) — NCT02980523.
- Registry record last updated 2019-05-22; status last verified 2019-05.
- Results first posted 2019-02-15.
- 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
NCT02980523 is recorded as a completed randomized, double-blind, parallel-group, phase II multicenter trial sponsored by Laboratorios Sophia S.A de C.V. It evaluated PRO-157, identified as pazufloxacin, in three dosing schedules against moxifloxacin and gatifloxacin for bacterial conjunctivitis. The recorded start was 2015-03 and primary completion was 2016-06.
The primary outcome was change in bacterial culture from baseline on day 1 to the final visit on day 8. The registry describes quantifying and identifying colony-forming units by genus and species and states an effectiveness criterion based on reduction of bacterial flora in at least 95% of evaluated subjects. Clinical signs and safety measures were also described.
The registry reports enrollment of 150, while its brief summary and arm descriptions give eye-level and subject-level descriptions that are not reconciled. Adverse-event counts are reported by group. Primary efficacy results, detailed statistical methods, multiplicity handling, and missing-data methods are not reported in the registry record.