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 Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms (NCT00761202), a randomized phase 4 study. The primary outcome is Conjunctival Staining by Lissamine Green.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00761202 |
| Phase | Phase 4 |
| Condition | Dry Eye Syndromes |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
Patients with mild to moderate dry eye symptoms, with and without contact lenses, were the intended population. The primary outcome specifies the Intent to Treat Population. The registry record lists an enrollment of 50, but does not provide further details about participant characteristics or how many participants contributed data to each outcome.
Intervention
One arm received Optive Eyedrops, described as a sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®. The brief summary says the drops were administered for one month. The registry record does not provide additional details about dosing or adherence.
Comparator
The comparison arm received Hylocomod Eyedrops, whose listed drug ingredient is sodium hyaluronate. The study compared the two eyedrop regimens in a randomized, parallel design. Further details about how the treatments were assigned or whether use with contact lenses affected treatment assignment are not reported in the registry record.
Primary question
The primary outcome was conjunctival staining by lissamine green, expressed as the percentage of participants at each point on a five point severity scale. Assessments were scheduled at week 1 and month 1. The clinical question is whether the observed staining distributions differed between the two treatment arms at those assessments. The registry record does not report the outcome values or an analysis answering that question.
3. Trial Design
The study is registered as a phase 4, randomized, single-masked, parallel-group trial. It compares Optive Eyedrops with Hylocomod Eyedrops in people with dry eye symptoms. The registry record lists enrollment of 50 and a completed status. The recorded study start is 2007-08 and primary completion is 2008-06. These dates describe the study record; they do not, on their own, establish when every participant was recruited or followed.
The brief summary describes patients with mild to moderate dry eye symptoms, with and without contact lenses, and treatment for one month. The arms are named Optive Eyedrops and Hylocomod Eyedrops. The first intervention is described as a sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®. The second is listed as sodium hyaluronate.
Randomization supports a planned comparison between assigned treatment groups, while a parallel design means the groups are compared across the same study period rather than participants crossing between treatments. “Single” masking is recorded, but who was masked and how masking was maintained are not reported in the registry record. The method used to generate the random allocation sequence and the procedures for concealing assignments are also not reported.
The primary outcome was assessed at week 1 and month 1. Other listed outcomes include corneal staining by fluorescein, conjunctival hyperaemia, ocular comfort and symptoms on a visual analogue scale, daily eyedrop usage, and lipid layer pattern assessment. The registry record lists six outcome measures in total. It does not provide detailed protocols for these assessments, their ordering, or the planned statistical comparisons.
The listed primary analysis population is the Intent to Treat Population. The registry record does not explain how that population was defined in practice, whether all randomized participants were included, or how missing outcome observations were handled. It also does not report the trial’s sample-size justification or a statistical analysis plan.
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 | Carboxymethylcellulose and Glycerin | Sodium Hyaluronate |
|---|---|---|
| STARTED | 22 | 28 |
| COMPLETED | 21 | 26 |
| NOT COMPLETED | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Intent to Treat Population
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 | Carboxymethylcellulose and Glycerin | Sodium Hyaluronate | Total |
|---|---|---|---|---|
| Participants analysed | 21 | 26 | 47 | |
| Age Continuous | years | 44.8 (SD 16.4) | 39.9 (SD 14.8) | 42.0 (SD 16.0) |
| Sex: Female, Male: Female | Participants | 16 | 20 | 36 |
| Sex: Female, Male: Male | Participants | 5 | 6 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Conjunctival Staining by Lissamine Green, measured over week 1, month 1.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is conjunctival staining by lissamine green. It is described as the percentage of cases of limbal staining at each point on a five point scale: 0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe. Assessments were scheduled at week 1 and month 1, and the specified population is the Intent to Treat Population.
This endpoint records the distribution of staining severity, rather than reducing the assessment to a single yes-or-no outcome. A percentage at each scale point can show whether participants were recorded as having no staining, trace staining, or greater severity. General statistical context: retaining ordered severity categories can preserve distinctions that would be lost if the measure were collapsed into a binary indicator. It also means that interpretation depends on seeing the category-specific results and knowing how observations were analyzed.
Lissamine green staining is an ocular-surface assessment included in the trial’s evaluation of dry eye symptoms. The registry record identifies the measure and assessment times, but does not describe the scoring procedures in further detail, report the category percentages, or provide a treatment comparison. Consequently, the endpoint definition establishes what was intended to be measured, but not what the trial found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of Optive and Hylocomod eyedrops and specifies conjunctival staining by lissamine green as the primary outcome. However, it does not report the primary outcome values, a treatment-effect estimate, a confidence interval, or a statistical test. No conclusion about the direction or size of a difference in staining can therefore be drawn from the posted results described in the record.
The outcome is recorded as percentages across the scale points 0 through 4 at week 1 and month 1. That is a set of category-specific results across assessment times, not a single scalar comparison. The registry record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This is why there is no single primary comparison presented for interpretation. Without the underlying values and an analysis method, it is not possible to assess whether categories shifted, how large any shift might be, or how precisely it was estimated.
The record lists an Intent to Treat Population for the primary outcome, but does not report the numbers analyzed at each assessment or the handling of participants with missing observations. The enrollment entry is 50; that alone does not establish the denominator for any particular outcome or time point. The separate safety figures list different numbers at risk in the treatment groups, but those safety denominators should not be substituted for primary-outcome denominators.
The posted safety figures record zero serious adverse events among 21 participants at risk in the carboxymethylcellulose and glycerin group, and zero among 26 at risk in the sodium hyaluronate group. Other adverse events are recorded as affecting 2 participants in each group. These are descriptive counts. The registry record does not provide event terms for those other adverse events, further detail about their severity or timing, or a comparative safety analysis. Death information is not reported in the registry record.
Because outcome estimates and uncertainty measures are absent, statistical significance, precision, and clinical importance cannot be assessed for the primary endpoint. A completed status does not fill this reporting gap. The record identifies the question and measures, but does not provide the results needed to judge the primary comparison.
9. Statistical Methods Explained
The trial is recorded as randomized, single-masked, and parallel. General statistical context: random allocation is intended to make treatment groups comparable at the outset, on average, for measured and unmeasured factors. It does not guarantee that groups will be identical in a particular trial, especially when enrollment is limited. A parallel design compares groups assigned to different treatments over the study period. The record does not report the randomization sequence method, allocation concealment, or who was masked.
What does the primary outcome represent?
The primary outcome describes the percentage of participants or cases at each lissamine green staining level, from 0 = None through 4 = Severe. Measurements are scheduled at week 1 and month 1. These are ordered categories: higher scale points indicate more severe staining, while the distances between adjacent categories are not necessarily equal. General statistical context: an analysis of an ordinal outcome can use the ordering of categories without assuming that the gap between every pair of scale points is the same. The registry record does not identify the statistical model or comparison planned for these category-specific results.
A percentage at each category answers a different descriptive question from a mean score or a binary percentage with any staining. The former retains the distribution across severity levels; the latter approaches would combine or summarize information differently. No conversion or collapse of the registry’s primary outcome is reported. The posted record also does not provide the percentages, denominators, or model estimates for the individual categories.
How should uncertainty be understood?
General statistical context: an estimate describes the observed contrast or outcome in the analyzed data. A confidence interval conveys how uncertain that estimate is under the assumptions of the analysis; a narrower interval indicates greater precision than a wider interval. A p-value, when reported, measures how compatible the data are with a specified null hypothesis under the statistical model. It does not measure the size or importance of an effect. No confidence intervals, p-values, or primary treatment-effect estimates are reported in the registry record, so none of these features can be evaluated for the primary endpoint.
General statistical context: categorical outcome percentages are influenced by the number of observations contributing to each category and time point. Small denominators can make percentages unstable, and missing observations can change which participants contribute to a particular assessment. The registry record does not report primary-outcome denominators, missingness, or methods for addressing missing data.
What do the analysis entries establish?
The registry record lists zero analyses. It also identifies a primary endpoint with multiple scale categories and assessment times that was not reduced to one comparison. Together, these details mean that the record does not present an inferential result for the primary endpoint. There is no reported model, test statistic, adjusted or unadjusted estimate, or uncertainty interval to interpret. It would not be appropriate to infer a result from the trial’s design or completion status.
General statistical context: a prespecified analysis plan helps distinguish confirmatory analyses from exploratory ones and can state how repeated measurements, multiple categories, covariates, and missing data will be treated. Those choices can affect estimates and uncertainty. The statistical plan, including any covariate adjustments or interim analyses, is not reported in the registry record. No claims about the use or absence of such procedures can be made beyond that reporting limitation.
What is the role of planning calculations?
General statistical context: sample-size planning uses assumptions about the expected effect, variability, significance level, allocation, and desired power to estimate how many participants might be needed. A planning illustration based on an observed effect is not a description of the trial’s original design and is not observed power. The record does not report the trial’s own sample-size justification. Any planning illustration should therefore be read as a hypothetical calculation under its stated assumptions, not as evidence that the trial had a particular probability of detecting an effect.
For this outcome, interpretation would require the category-specific observations at each scheduled assessment, a stated treatment contrast, and an uncertainty measure. Without those elements, neither the magnitude nor the precision of a primary treatment difference can be characterized. The available record supports a description of the design and endpoint, not a reconstruction of unreported analyses.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed across multiple severity categories and at week 1 and month 1. The registry record does not reduce those results to one comparison and lists zero analyses. It does not report a strategy for controlling multiplicity, such as selecting a primary time point, defining a global test, or adjusting inference across categories or assessment times. These details are not reported in the registry record, so the inferential consequences of multiple comparisons cannot be evaluated.
Several additional outcomes are listed: corneal staining by fluorescein, conjunctival hyperaemia, ocular comfort and ocular symptoms on a visual analogue scale, daily eyedrop usage, and lipid layer pattern assessment. The record does not state which secondary outcome comparisons were planned as confirmatory, how their multiplicity would be addressed, or whether analyses were conducted. Listing an outcome does not establish that its results were analyzed or reported.
The primary outcome names the Intent to Treat Population, but procedures for applying that population are not described. The numbers with observed data at each assessment and the reasons for missing observations are not reported in the registry record. Methods for handling missing outcomes, withdrawals, or protocol deviations are also not reported. General statistical context: missing-data handling matters because the analyzed participants may differ from those with missing measurements; assumptions about those unobserved results can affect estimates.
The registry record also does not report whether outcome definitions or analysis choices changed during the study. Without a statistical analysis plan and an account of missingness, it is not possible to distinguish planned analyses from decisions made after results were available. These gaps limit assessment of the completeness and confirmatory status of any results.
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 |
|---|---|---|---|
| Carboxymethylcellulose and Glycerin | 0 | 21 | 0.0% |
| Sodium Hyaluronate | 0 | 26 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Carboxymethylcellulose and Glycerin | 2 of 21 |
| Sodium Hyaluronate | 2 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Carboxymethylcellulose and Glycerin | Sodium Hyaluronate |
|---|---|---|---|
| Mild Corneal Toxicity | Eye disorders | 1 of 21 | 1 of 26 |
| Upper Lid Cyst | Eye disorders | 0 of 21 | 1 of 26 |
| Foot Injury | Injury, poisoning and procedural complications | 1 of 21 | 0 of 26 |
The safety record separates serious adverse events from other adverse events. In the carboxymethylcellulose and glycerin group, 0 serious adverse events are recorded among 21 participants at risk, and 2 participants are recorded as affected by other adverse events among 21 at risk. In the sodium hyaluronate group, 0 serious adverse events are recorded among 26 participants at risk, and 2 are recorded as affected by other adverse events among 26 at risk.
These figures are counts, not a comparative statistical analysis. They do not establish whether an observed difference between groups is meaningful, and the zero serious-event counts do not establish that the treatments have no safety risks. The registry record does not list the terms for the other adverse events, their timing, severity, or relationship to treatment. It also does not report death counts; the death entries are not reported in the registry record.
The safety denominators differ from the overall enrollment entry and should be interpreted as the numbers recorded at risk for these safety summaries. They should not be assumed to be the primary-outcome analysis denominators. More detailed safety interpretation would require event descriptions, follow-up information, and a prespecified comparison.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, single-masked, parallel phase 4 comparison of Optive and Hylocomod eyedrops was completed, with enrollment listed as 50. It specifies a primary staining assessment at week 1 and month 1 in the Intent to Treat Population. It also describes other ocular outcomes and records a small set of safety counts. These registry entries describe the intended evaluation and the limited results available in the record.
The record does not establish whether one eyedrop produced less staining, whether participants reported different symptoms, or whether treatment groups differed on the other listed outcomes. The primary outcome values and statistical analyses are not reported. There is no treatment-effect estimate or confidence interval from which to judge the size or precision of a difference. No claim that either treatment works or does not work follows from the absence of these results.
Likewise, the safety counts should not be read as proof of equivalent safety. Zero serious adverse events are recorded in both groups, while other adverse events are recorded for participants in each group. Without event descriptions, a defined comparative analysis, and fuller follow-up information, these counts are descriptive rather than conclusive.
General statistical context: a trial’s design can support a fair comparison, but the strength of the resulting evidence also depends on complete outcome reporting, appropriate analyses, and transparent handling of missing data and multiple comparisons. The registry record does not report those analysis details. Its completed status indicates that the study is recorded as completed; it does not substitute for primary-outcome results.
The most defensible reading is therefore narrow: the registry describes the treatment comparison and endpoint, but does not provide the evidence needed to quantify or assess the primary outcome difference. The listed secondary outcomes and safety data should be understood within the same reporting limits.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary endpoint is a distribution across ordered staining categories, measured at more than one assessment time. Such an outcome cannot be adequately represented by a single treatment contrast without specifying how categories and times are handled. The registry record explicitly does not reduce the endpoint to one comparison, and it lists zero analyses. As a result, the central statistical question remains unanswered in the reported record.
The distinction between an endpoint definition and an endpoint result is important. Naming the scale, assessment times, and analysis population tells readers what the investigators intended to measure. It does not reveal the observed category distribution, the treatment contrast, or its uncertainty. Without those results, readers cannot judge the size, direction, precision, or clinical relevance of a difference.
The record also illustrates why planning information and completed-trial evidence should not be conflated. Sample-size illustrations based on observed effects are hypothetical planning exercises, not observed power and not a substitute for a reported estimate with uncertainty. The trial’s own sample-size justification is not reported in the registry record.
Finally, safety counts need context. The recorded serious and other adverse event counts are useful descriptive information, but event terms and comparative analysis are absent. The record therefore supports a careful account of what was registered and what was counted, while leaving the main efficacy comparison and a fuller safety interpretation unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation is the absence of reported primary-outcome results. The registry record specifies lissamine green staining across five severity points at week 1 and month 1, but gives no category percentages, denominators, treatment contrast, or uncertainty estimate. It also lists zero analyses and notes that the primary outcome was not reduced to one comparison. The size and precision of any difference therefore cannot be assessed.
The primary endpoint’s multiple categories and assessment times require an explicit analysis approach for interpretable inference. The statistical analysis plan, treatment of repeated assessments, multiplicity strategy, and any covariate adjustments are not reported in the registry record. The record also does not say whether there were interim analyses or whether outcome definitions changed.
Although the primary population is identified as the Intent to Treat Population, its operational definition and the number of participants contributing outcome data are not reported. Missing-data frequency, reasons for missingness, and methods for handling missing observations are also not reported. Enrollment of 50 does not establish the number analyzed at each outcome assessment.
The single-masked label is not accompanied by details about who was masked or how masking was maintained. Further design information, including the randomization and allocation-concealment methods, is not reported. The record lists secondary outcomes but provides no analysis results for them. Safety data lack event descriptions and comparative analysis, and death information is not reported in the registry record. These limitations constrain interpretation of both the primary question and the broader clinical profile of the comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms — NCT00761202.
- Registry record last updated 2013-11-19; status last verified 2013-10.
- Results first posted 2010-02-04.
- 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
NCT00761202 is recorded as a completed, randomized, single-masked, parallel phase 4 trial comparing Optive Eyedrops with Hylocomod Eyedrops in patients with mild to moderate dry eye symptoms, with and without contact lenses. Enrollment is listed as 50. The study dates are recorded as 2007-08 for start and 2008-06 for primary completion.
The primary outcome is conjunctival staining by lissamine green, recorded as the percentage at each point on a five point severity scale at week 1 and month 1 in the Intent to Treat Population. The registry record does not report primary outcome values or analyses. Safety entries record zero serious adverse events in each group and other adverse events affecting 2 participants in each group. Event details and death information are not reported in the registry record.