This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants (NCT05992922), a randomized phase 2 study. The primary outcome is Ocular Discomfort and Dry Eye Symptoms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05992922 |
| Phase | Phase 2 |
| Condition | Dry Eye Syndromes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Iacta Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Adults diagnosed with dry eye disease. The registry record describes an intent-to-treat population, but notes that only 14 participants in the IC265 arm and 19 in the vehicle arm reached Day 15 for the primary endpoint.
Intervention
IC265 Ophthalmic Solution 1%, with 1 drop instilled in each eye twice daily.
Comparator
Placebo Ophthalmic Solution (Vehicle), also with 1 drop instilled in each eye twice daily.
Primary question
The trial planned to assess the change from baseline in ocular discomfort and dry eye symptoms after a controlled adverse environment assessment on Day 15. The registry describes symptom ratings but does not report a numerical treatment comparison or analysis result.
The primary measure combines ratings of overall ocular discomfort, burning, dryness, grittiness and stinging. Participants rated how both eyes felt in general using a scale from 0, none, to 5, worst. This makes the clinical question about reported symptom severity, rather than a direct measure of another aspect of eye health.
The study record describes a safety, tolerability and efficacy comparison. Its stated primary endpoint is a change-from-baseline symptom measure at a specified assessment. Because endpoint results and an analysis are not reported in the registry record, the record does not establish how the groups compared on symptoms. The trial's status is terminated; the reason for termination is not reported in the registry record.
3. Trial Design
This was a Phase 2, randomized, parallel-group, placebo-controlled study of IC265 Ophthalmic Solution 1% for dry eye disease. The registry lists 40 participants enrolled and identifies Iacta Pharmaceuticals as the sponsor. The official title describes the study as single-center and double-masked, while the registry's masking classification is quadruple. Those labels are not reconciled in the registry record, so the precise masking arrangements cannot be clarified from the record alone.
Participants were assigned to IC265 or placebo vehicle. The listed dosing instructions were the same for both groups: 1 drop in each eye twice daily. The record describes the study population as adults diagnosed with dry eye disease and frames the study as assessing safety, tolerability and efficacy.
The study start date is 2023-10-17, and the primary completion date is 2023-12-19. The status is terminated. The record does not report why the study was terminated, whether the planned recruitment was completed, or whether the termination changed the planned analyses.
The primary endpoint was symptom change from baseline after a controlled adverse environment assessment on Day 15. The registry says only 14 participants in the IC265 group and 19 in the vehicle group reached Day 15 for this measure. That information signals that the endpoint population was smaller than the enrolled population, but the record does not explain why participants did not reach the assessment or whether other participants contributed to any other analyses.
Although the record lists nine outcome measures, it reports no analyses. It therefore does not give a primary-endpoint estimate, uncertainty measure or statistical comparison. Further details about randomization procedures, allocation concealment, visit schedules, treatment duration beyond the stated endpoint timing, and the statistical analysis plan 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 | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 20 | 20 |
Reasons for not completing this period:
| Reason | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) |
|---|---|---|
| Adverse Event | 6 | 0 |
| Sponsor Termination of Study | 14 | 20 |
Analysis population for the primary outcome, as defined in the registry: Intent to Treat - only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15.
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 | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) | Total |
|---|---|---|---|---|
| Participants analysed | 20 | 20 | 40 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 10 | 11 | 21 |
| Age, Categorical: >=65 years | Participants | 10 | 9 | 19 |
| Age, Continuous | years | 68.4 (SD 8.48) | 65.8 (SD 11.5) | 67.1 (SD 10.06) |
| Sex: Female, Male: Female | Participants | 11 | 13 | 24 |
| Sex: Female, Male: Male | Participants | 9 | 7 | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 | 20 | 40 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Ocular Discomfort and Dry Eye Symptoms, measured over Change from Baseline Post-CAE® (controlled adverse environment) Day 15.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in ocular discomfort and dry eye symptoms, assessed after a controlled adverse environment (CAE) on Day 15. Participants rated overall ocular discomfort, burning, dryness, grittiness and stinging, considering how both eyes felt in general. Each symptom used a 0-to-5 scale, with 0 meaning none and 5 meaning worst. The measure is described as a mean with standard deviation.
A symptom rating can capture a participant's experienced burden, which may not be represented by an examination finding alone. In general, measuring change from baseline focuses on how ratings shift during a study, while retaining the baseline as the reference point. A controlled assessment setting can also provide a standardized context for collecting symptom ratings. These are general reasons such measures and assessment settings may be used; the specific rationale for choosing this endpoint is not reported in the registry record.
The endpoint description names several symptoms, but no numerical baseline values, Day 15 values, change estimates or group comparison are reported in the registry record. The record also does not specify a single combined score formula or provide separate numerical results for each symptom. Consequently, the endpoint's measurement framework is described, but the amount or direction of symptom change cannot be determined from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study as randomized and placebo-controlled, and it gives the primary symptom endpoint and its assessment time. It does not, however, report an analysis of that endpoint. The count of analyses is zero, and the record contains no numerical group estimates, treatment contrast, confidence interval or p-value for the primary outcome. Accordingly, there is no reported efficacy comparison to interpret.
For the Day 15 endpoint, the record notes that 14 participants in the IC265 group and 19 in the placebo group reached the assessment. These figures describe endpoint availability, not the observed symptom effect. The record does not give reasons for participants not reaching Day 15, nor does it explain how unavailable measurements were handled. Without outcome values and an analysis population definition beyond the registry's intent-to-treat label, the impact of missing endpoint data cannot be assessed.
The safety information reports one serious adverse event among 20 participants at risk in the IC265 group and none among 20 at risk in the placebo group. The record lists Glioma as a top serious term at 5.0%, but does not give enough detail in that term listing to establish its relationship to an arm. Other adverse events are reported for 20 participants at risk in the IC265 group and 5 among 20 at risk in the placebo group. No deaths are reported in either group. These counts describe what the registry records; they do not by themselves establish causation or comparative safety.
The study is marked terminated. That status does not explain why the study stopped, whether stopping was related to safety or another reason, or whether it changed the planned outcome assessments. Such information is not reported in the registry record.
In general, a treatment estimate describes the observed difference between groups, while a confidence interval conveys the range of values compatible with the data under the analysis assumptions. Neither is available for the primary endpoint. The registry therefore supports a description of the design, endpoint, assessment availability and posted safety counts, but not a conclusion about the size, precision or statistical evidence of a symptom difference between groups.
9. Statistical Methods Explained
The study is described as randomized, parallel-group and placebo-controlled. In general, random assignment is intended to reduce systematic differences between groups at the start of a trial. A parallel design compares groups followed under their assigned interventions, while a placebo control provides a comparison condition. These design features help frame a treatment comparison, but they do not substitute for reporting the outcome estimates and analysis methods. The registry record does not give details of how randomization was generated or concealed.
What does a mean and standard deviation describe?
The primary endpoint is listed as a mean with standard deviation. In general, a mean represents the average of the recorded values in a group, and a standard deviation describes how dispersed individual values are around that average. The standard deviation is not the same as the uncertainty of the estimated mean or of a difference between groups. A confidence interval for a mean or treatment contrast would address estimation uncertainty, but none is reported for this endpoint.
The endpoint is a change from baseline in symptom ratings. In general, a change score is calculated from a participant's follow-up measurement relative to their baseline measurement. Group-level summaries of change can then be compared, depending on the chosen analysis method. The registry record does not report the baseline or follow-up values, the change estimates, or the method used to compare groups. It also does not report whether the individual symptom ratings were analyzed separately or combined according to a prespecified scoring rule.
Why does the assessment scale matter?
The symptom ratings use a 0-to-5 scale, anchored at none and worst. In general, such ratings are ordered categories: a higher value indicates a more severe rating, but the spacing between neighboring values is not necessarily identical in subjective meaning. A mean can still be a useful summary in some analyses, but interpretation depends on the scale, the distribution of responses and the analysis plan. The registry labels the endpoint as a mean and standard deviation; it does not report distributional summaries or explain the statistical rationale for that choice.
The endpoint is measured after a controlled adverse environment assessment. In general, a standardized assessment context may help make symptom measurement more consistent across participants. It does not remove the need to report how measurements were collected, how missing assessments were handled, and how the treatment comparison was estimated. Those analytic details are not reported in the registry record.
What does the absence of an analysis mean?
The registry lists nine outcome measures but reports zero analyses. This means the record does not present an analysis result for the primary endpoint or a statistical comparison that can be interpreted. It is not possible to infer an effect estimate from the enrolled count or the number of participants who reached Day 15. A result requires observed outcome data and a stated analysis; neither is reported for the primary endpoint.
In general, a p-value evaluates how compatible the observed data are with a specified statistical model and null hypothesis. A confidence interval describes uncertainty around an estimated quantity. Neither measure establishes the clinical importance of an effect by itself. Because the registry does not report a p-value, confidence interval or primary treatment estimate, statistical significance and precision cannot be assessed. The statistical analysis plan, including the model and any covariate adjustments, is not reported in the registry record.
How should planning calculations be understood?
In general, sample-size planning illustrations use assumptions about the effect to detect, variability, significance level, allocation and analysis method. The record describes a planning approach based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation and a normal approximation. It also specifies that non-time-to-event planning quantities are expressed as participants per arm. These are descriptions of a planning illustration, not evidence that the trial was designed with those assumptions, and they are not observed power. The registry does not report the trial's own sample-size justification. No numerical planning results are reported in the registry record.
Over-dispersion is a general concern when outcome variability is greater than a statistical model assumes; if ignored, uncertainty may be understated. The registry does not report a model or distributional assessment for this endpoint, so there is no basis to determine whether over-dispersion was relevant or how it was addressed. More generally, the absence of analyses prevents evaluation of model fit, robustness or sensitivity to alternative assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The record lists nine outcome measures, but it does not report analyses for them. It therefore does not explain which outcomes were designated primary or secondary beyond the listed primary endpoint, how multiple comparisons were handled, or whether any adjustment to control false-positive findings was planned. The primary outcome description also encompasses several symptom categories. The registry record notes that this outcome has several categories or time points and was not reduced to one comparison. No category-specific statistical estimates are reported.
Multiplicity is a general issue when several outcomes, time points or comparisons are tested: the more opportunities there are to identify a result, the harder it can be to interpret isolated statistical findings without a prespecified approach. That concern cannot be quantified for this trial from the registry record because no analysis plan or outcome results are reported.
The endpoint population is described as intent to treat, with only 14 participants in the IC265 group and 19 in the placebo group reaching Day 15. The record does not state how participants without a Day 15 measurement were treated in the analysis, whether measurements from other visits were used, or whether any imputation or sensitivity analysis was performed. The amount and pattern of missingness beyond the Day 15 reach counts are not reported.
In general, missing data can affect both the precision and the validity of a treatment comparison, particularly when the reasons measurements are unavailable differ across participants or groups. The registry does not report reasons for nonattendance, withdrawal details, adherence, or the analysis population used for the posted safety counts. As no outcome analysis is reported, the effects of missing data and multiplicity remain unresolved.
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 |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | 1 | 20 | 5.0% |
| Placebo Ophthalmic Solution (Vehicle) | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IC265 Ophthalmic Solution 1% | 0 of 20 |
| Placebo Ophthalmic Solution (Vehicle) | 0 of 20 |
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 |
|---|---|
| IC265 Ophthalmic Solution 1% | 20 of 20 |
| Placebo Ophthalmic Solution (Vehicle) | 5 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) |
|---|---|---|---|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 20 | 0 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IC265 Ophthalmic Solution 1% | Placebo Ophthalmic Solution (Vehicle) |
|---|---|---|---|
| Instillation site irritation | Eye disorders | 15 of 20 | 2 of 20 |
| Corneal Opacity | Eye disorders | 11 of 20 | 0 of 20 |
| Vision Blurred | Eye disorders | 5 of 20 | 1 of 20 |
| Eye Pruritus | Eye disorders | 2 of 20 | 0 of 20 |
| Visual Acuity reduced | Eye disorders | 1 of 20 | 1 of 20 |
| Corneal neovascularisation | Eye disorders | 0 of 20 | 1 of 20 |
| Instillation site foreign body sensation | Eye disorders | 1 of 20 | 0 of 20 |
| Lacrimation Increased | Eye disorders | 1 of 20 | 0 of 20 |
Serious events with the highest arm-level rate: glioma (5.0%).
The safety counts are reported separately for the two groups. For serious adverse events, the record lists 1 affected participant among 20 at risk in the IC265 group and 0 among 20 at risk in the placebo group. It reports 0 deaths in each group. The registry also lists Glioma among the top serious terms at 5.0%; the term listing does not provide enough detail to establish an arm-specific association.
For other adverse events, the record lists 20 affected participants among 20 at risk in the IC265 group and 5 among 20 at risk in the placebo group. These are counts in the registry record, not a causal assessment. A reported event occurring during a trial does not, by itself, show that the assigned intervention caused it. The record does not provide event-level descriptions, timing, severity breakdowns beyond the serious-event information, or an assessment of relatedness.
In general, adverse-event counts are interpreted in the context of how events were defined and collected, participant exposure, follow-up duration and the completeness of reporting. Those details are not reported in the registry record. The counts alone also do not establish whether a difference between groups is statistically reliable or clinically meaningful.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized comparison of IC265 Ophthalmic Solution 1% with placebo vehicle for dry eye disease, and it identifies a symptom-change endpoint assessed after a controlled adverse environment on Day 15. It also reports how many participants reached that assessment in each group and gives group-level adverse-event counts. These details allow readers to understand the intended comparison and some aspects of endpoint availability and safety reporting.
The record does not report numerical primary-endpoint results or any analysis. It therefore does not establish the direction or size of a symptom change, the difference between groups, or the precision of such a difference. It also does not support a conclusion about statistical significance. No inference about symptom benefit or lack of benefit follows from the absence of a posted analysis.
The safety counts document events recorded in the registry, including one serious adverse event in the IC265 group, none in the placebo group, and no deaths in either group. Those observations do not by themselves show that an event was caused by treatment or provide a complete comparative safety assessment. The event term listing and the limited detail about event collection constrain interpretation.
The study's terminated status is relevant context, but the reason for termination is not reported in the registry record. It cannot be assumed that termination was caused by safety findings, lack of efficacy, recruitment difficulties or any other particular circumstance. Likewise, the registry does not explain how termination affected endpoint collection or analysis.
In general, a clinical trial result is most informative when the planned comparison, observed estimates, uncertainty, analysis population and missing-data handling are available together. The registry record supplies design and endpoint descriptions but not that complete statistical account. Its contents should therefore be read as a record of the trial's stated design and posted counts, rather than as a demonstrated treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record describes a randomized, placebo-controlled comparison but reports no analyses. That distinction matters: design information explains how a comparison was intended to be made, while outcome estimates are needed to assess what the observed data show. Without primary-endpoint results, the intended symptom comparison cannot be quantified or judged for precision.
The endpoint is based on participant ratings across several symptoms and is scheduled after a controlled assessment. This illustrates general questions that recur in clinical research: how subjective measures are summarized, whether related symptoms are combined, and how a result is interpreted when the endpoint includes multiple categories. The record does not report a combined-score rule or category-specific estimates, so those questions remain open for this study.
The Day 15 reach counts also emphasize the distinction between enrollment and endpoint availability. The record identifies 40 enrolled participants but notes that only 14 in the IC265 group and 19 in the placebo group reached the primary endpoint assessment. Without the analysis population, missing-data strategy or outcome values, the effect of this endpoint availability on inference cannot be evaluated.
Finally, the safety counts are descriptive rather than causal, and the terminated status lacks an accompanying reason. Together, these features show why statistical interpretation depends on transparent reporting of analyses, uncertainty, missingness and study conduct, not only on a trial's randomized design or its listed outcomes.
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 most direct limitation for interpreting efficacy is that no primary outcome analysis is reported in the registry record. There are no symptom estimates, treatment contrasts, confidence intervals or p-values. The record therefore cannot establish the magnitude, direction or precision of a group difference.
Only 14 participants in the IC265 group and 19 in the placebo group reached the Day 15 endpoint assessment, while enrollment is listed as 40. The reasons for the difference between enrollment and endpoint availability are not reported. The record also does not describe missing-data handling, withdrawals, adherence, baseline symptom values or the analysis population used for an outcome comparison.
The endpoint description lists several symptoms but does not give a scoring rule for combining them or separate numerical results by symptom. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. Without analyses, it is not possible to assess multiplicity or determine how the endpoint was operationalized statistically.
The registry reports a terminated status without a reason. The record also gives differing masking labels: the official title says double-masked, while the registry classification says quadruple. Further details about the masking procedures, randomization implementation, statistical plan and sample-size justification are not reported in the registry record. These limits constrain interpretation of both efficacy and safety and prevent assessment of how closely the completed study followed its intended methods.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants — NCT05992922.
- Registry record last updated 2025-04-25; status last verified 2024-09.
- Results first posted 2025-04-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The record describes a Phase 2, randomized, parallel, placebo-controlled study of IC265 Ophthalmic Solution 1% in adults with dry eye disease. It lists 40 participants enrolled and gives matching twice-daily dosing instructions for IC265 and vehicle. The study is marked terminated; the reason is not reported in the registry record.
The primary endpoint is change from baseline in ocular discomfort and dry eye symptoms after a controlled adverse environment assessment on Day 15, using ratings from 0 to 5. The record notes that 14 participants in the IC265 group and 19 in the placebo group reached Day 15. It lists nine outcome measures and zero analyses, so no primary outcome comparison is available.
Safety entries include one serious adverse event in the IC265 group, none in the placebo group, and no deaths in either group. Other adverse events are also recorded. The posted information supports a description of the trial design and counts, but not a conclusion about comparative symptom outcomes or causation of adverse events.