A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (NCT05335122), a randomized phase 2 study. The primary outcome is IOP Changes From Baseline in the Study Eye.

2. Clinical Question

In statistical terms, the trial asks whether the observed pressure changes over the specified follow-up periods differ across the randomized treatment groups. The outcome is continuous and summarized as a mean with standard deviation. That summary describes the average change while also conveying how much individual measurements varied around the average. The record identifies one primary outcome measure but lists several time points and measurement times within it. Those repeated measurements make the interpretation more detailed than a single treatment contrast at one follow-up visit.

3. Trial Design

This was a prospective, multicenter, randomized, double-masked, parallel-group, controlled Phase 2 study. The registry lists an enrollment of 83 and describes three treatment groups: OTX-TIC low dose, OTX-TIC high dose, and Durysta. Participants were assigned to one of these groups, and the parallel-group design means the groups were followed separately rather than participants crossing from one assigned treatment to another.

The study began on 2022-03-16, reached primary completion on 2024-01-24, and is listed as completed. The sponsor was Ocular Therapeutix, Inc. These registry entries describe the trial’s organization and status; they do not establish how treatment assignment was generated, how masking was maintained, or what procedures were used to preserve allocation concealment. Those details are not reported in the registry record.

The registry’s brief summary describes evaluation of efficacy and safety after a single sustained-release dose of OTX-TIC, using two travoprost dose strengths. Durysta is listed as the active comparator, with a bimatoprost intracameral implant 10 µg. The record identifies the study as randomized and double-masked, but does not report the exact randomization method, whether allocation was stratified, or which people were masked.

The primary outcome is change from baseline in study-eye intraocular pressure at Week 2, Week 6, and Week 12, with measurements at 8 AM, 10 AM, and 4 PM. The analysis population is described as mITT according to treatment received, including subjects who received an investigational product in the study eye. The registry record does not report the number analyzed in each treatment group or explain how missing measurements were handled. Those omissions limit assessment of the analysis set and the comparability of the groups contributing outcome data.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analysis was performed on the mITT population according to the treatment received. The mITT population included all subjects who received an investigational product (OTX-TIC or Durysta) in the study eye \[SE\]. The SE is defined as the eye that meets the entry criteria. If both eyes qualify for study entry the SE will be selected on the basis of the eye with the highest IOP at baseline. Data collected after the receipt of IOP lowering medication (rescue therapy) will be treated as missing.

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: Baseline characteristics will be based on mITT population.

6. Primary Endpoint

The registry lists the primary outcome as IOP Changes From Baseline in the Study Eye, measured over Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM).

The primary endpoint measures change from baseline in intraocular pressure (IOP) in the study eye. IOP is the pressure measure named by the trial’s primary outcome; the record reports it in millimeters of mercury (mmHg). The outcome is assessed at Week 2, Week 6, and Week 12, using readings taken at 8 AM, 10 AM, and 4 PM. The registry describes the outcome parameter as a mean and its dispersion as a standard deviation.

As a general statistical concept, change from baseline expresses follow-up measurements relative to each participant’s starting value. It can help characterize how an outcome shifts over time while accounting for the starting measurement in the outcome definition. A group mean summarizes the average change, while a standard deviation describes the spread of individual changes around that mean. The mean alone does not show how variable participants’ responses were.

Repeated measurement times and follow-up visits can reveal whether the average pattern is similar across the day and over follow-up. They also create multiple values to interpret: a result at one time cannot automatically be treated as a result at another time. The record does not report numerical means, standard deviations, treatment contrasts, confidence intervals, or p-values for this endpoint. Consequently, the direction, magnitude, and precision of the primary outcome findings are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a continuous measure: change in study-eye IOP from baseline. A continuous outcome can take a range of values rather than belonging to a set of categories. The record summarizes this outcome using a mean and standard deviation. As a general statistical explanation, the mean describes the center of observed values, while the standard deviation describes their spread. Neither measure, by itself, gives the uncertainty around a comparison between treatment groups.

What does a treatment contrast represent?

A treatment contrast compares an outcome summary between groups. For a continuous endpoint, a contrast might express how far apart group means are, with the sign depending on the order of subtraction. A confidence interval around a contrast describes a range of values compatible with the data and the analysis assumptions. It conveys precision, not the probability that a particular treatment effect is true. The registry record does not report a primary-outcome contrast or confidence interval, so neither the estimated magnitude nor its precision can be assessed.

Why does the standard deviation matter?

The standard deviation helps show how much participant-level measurements vary around a group mean. A small standard deviation relative to the spread between group means can make a group contrast more precisely estimated, while substantial within-group variability can make it less precise. This is a general explanation, not a conclusion about this trial: the endpoint’s numerical standard deviations are not reported in the registry record.

How should repeated measurements be understood?

The endpoint includes measurements at three times of day and at Week 2, Week 6, and Week 12. Measurements taken from the same participant are generally related, rather than independent observations. As a general principle, analyses of repeated measures should account for that dependence or define a suitable participant-level summary. Ignoring the dependence can misstate uncertainty. The registry record does not report the statistical model, any within-participant correlation structure, or whether values were combined across times or analyzed separately. It is therefore not possible to determine how repeated measurements were incorporated.

What does randomization contribute?

In general, random assignment aims to make treatment groups comparable at the start of a trial with respect to both measured and unmeasured characteristics. It supports causal interpretation when the assigned groups are retained in the analysis, outcome measurement and follow-up are handled appropriately, and other assumptions are reasonable. Randomization does not guarantee exact balance in a particular trial. The registry identifies this study as randomized, but does not report the assignment sequence, allocation concealment procedures, or baseline balance details.

What does double masking contribute?

Masking is intended to limit the influence of treatment knowledge on behavior, care, or outcome assessment. The registry labels the trial double-masked, but does not specify who was masked or how masking was maintained. That information matters when assessing whether expectations could have influenced measurements, reporting, or decisions during follow-up. The label alone does not establish how masking worked in practice.

How should safety counts be compared?

Adverse-event counts are descriptive summaries. A formal comparison would need to consider the number of participants at risk, the event definitions, the follow-up period, and uncertainty around group differences. For events that can occur more than once, participant counts and event counts answer different questions. The registry reports participants affected for serious and other adverse events, but does not report inferential comparisons or confidence intervals. General statistical reasoning therefore supports caution about treating differences in these counts as evidence of a treatment effect.

What can planning calculations tell readers?

As a general concept, a sample-size calculation estimates how many participants per arm might be needed for a specified power, significance level, allocation, and target effect under stated assumptions. Such a calculation is prospective and illustrative; it is not a measure of the probability that a completed trial detected an effect. The registry record describes an illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It does not report a numerical observed effect or the resulting participant counts in the information available for interpretation. Without those inputs and outputs, no particular planning estimate can be assessed.

The registry lists no analyses for the primary outcome, and numerical estimates, confidence intervals, and p-values are not reported in the registry record. Statistical significance, if reported, would not by itself convey the clinical importance or precision of an effect. In the absence of the primary outcome results and the analysis details, the design and endpoint can be explained, but the treatment-effect evidence cannot be reconstructed.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint covers multiple assessment occasions: Week 2, Week 6, and Week 12, each with readings at 8 AM, 10 AM, and 4 PM. Considering multiple treatment groups and multiple measurement occasions raises a general multiplicity issue: the more comparisons examined, the greater the chance that at least one appears notable by chance if the analysis does not account for the number of comparisons. The registry record does not report whether comparisons were prioritized, adjusted for multiplicity, or interpreted under a prespecified hierarchy. It does not report a statistical analysis plan.

The record describes one primary outcome measure, but this is not the same as documenting one statistical comparison. The outcome definition contains several measurement times, and the registry’s listed analyses count is zero. Numerical results for the primary endpoint are not reported in the registry record. No statement about statistical significance across the time points can therefore be supported from the available outcome information.

The outcome population is described as mITT according to treatment received. It includes subjects who received OTX-TIC or Durysta in the study eye. This is not described as an intention-to-treat analysis of everyone randomized. The registry record does not report how many randomized participants received treatment, how many contributed endpoint data, or whether the analysis population differed by outcome visit.

Missing data procedures are not reported in the registry record. The record does not explain whether missed measurements were imputed, excluded, or handled through a model, nor does it state assumptions about why measurements could be missing. As a general principle, missing-data methods can affect estimates and uncertainty, especially when the likelihood of missingness is related to treatment or outcome. Without the methods and analysis counts, readers cannot assess that potential influence.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: rib fracture (6.2%), iritis (3.1%), fall (3.1%), electrolyte imbalance (3.1%), mental status changes (3.1%).

The safety summaries count participants affected in each group. Serious adverse events were reported for 1 of 16 participants in the OTX-TIC 5 µg group, 6 of 32 in the OTX-TIC 26 µg group, and 4 of 34 in the Durysta group. Other adverse events were reported for 12 of 16, 20 of 32, and 8 of 34, respectively. Deaths are listed as 0 in each group. These are descriptive counts; the registry record does not report comparative statistical analyses or confidence intervals for them.

The record lists Rib Fracture at 6.2%, with Iritis, Fall, Electrolyte Imbalance, Mental Status Changes, and Renal Impairment each at 3.1%, as top serious terms. It does not report the denominator or specify how these term percentages relate to individual treatment groups. These figures should therefore be read as registry-listed terms and percentages, not as group-specific comparative estimates.

As a general statistical point, safety comparisons are affected by the number of participants observed, the duration of observation, and whether events are counted as participants affected or as repeated occurrences. The registry record does not provide enough detail to assess all of these considerations. The counts describe what was reported, but do not establish that a treatment caused an event or that differences between groups are reliable.

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

The registry record establishes that a randomized, double-masked, parallel-group Phase 2 study compared two OTX-TIC travoprost implant doses with Durysta in people with open-angle glaucoma or ocular hypertension. It defines the primary outcome as change from baseline in study-eye IOP at Week 2, Week 6, and Week 12, measured at 8 AM, 10 AM, and 4 PM. It also reports descriptive safety counts and the absence of deaths in the listed groups.

Those details do not show the size or direction of the primary outcome changes. Numerical group means, standard deviations, treatment contrasts, confidence intervals, and p-values for IOP are not reported in the registry record. Readers therefore cannot determine from this record whether group averages differed, how large any difference was, or how precise an estimate would be. Missing outcome results should not be interpreted as evidence that treatments had the same effect or that one treatment was better.

The safety summaries also do not, on their own, establish comparative safety. Counts of participants affected can provide a descriptive overview, but the registry does not report uncertainty estimates or statistical tests for group differences. The serious-term percentages lack enough context in the record to support treatment-specific interpretation.

As a general principle, results from a randomized trial are interpreted alongside the analysis population, outcome definitions, statistical methods, completeness of follow-up, and uncertainty around estimates. The registry identifies an mITT population according to treatment received, but does not fully report the analysis procedures or missing-data handling. The record is therefore informative about the trial’s design and planned outcome, while leaving important evidence about the primary treatment comparisons unavailable.

No medical conclusion follows from these limitations. The distinction is between what the record documents and what it does not: the trial’s structure and certain safety counts are described, while numerical primary-outcome findings and their precision are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises several statistical issues that are important for interpreting clinical research. First, the design compares two doses of one investigational implant with an active comparator. That structure requires attention to which contrasts are of interest and how conclusions are framed across the treatment groups. The registry identifies the groups but does not report a hierarchy of comparisons or a statistical plan.

Second, the primary outcome is measured repeatedly across visits and times of day. Repeated measurements can characterize patterns that a single measurement would miss, but they also require careful analysis because observations from the same person are related. A clear analysis description helps readers understand which time points support a conclusion and how uncertainty was calculated. Those details are not reported in the registry record.

Third, the registry describes a treatment-received mITT population. Analysis populations matter because estimates can depend on who is included, how participants are assigned to groups, and whether all randomized participants contribute data. The record does not report group-specific analysis counts or a full account of missing observations, limiting assessment of these choices.

Finally, statistical interpretation depends on estimates and their precision, not only on a trial’s design or a summary of safety events. The record does not report numerical primary-outcome results, so the effects and their uncertainty cannot be evaluated. This illustrates why registrations and posted results serve different purposes: design information clarifies the question, while numerical outcomes and analysis details are needed to assess the evidence. The safety counts are useful descriptive information, but they cannot fill the gap in the primary outcome results.

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 limitation for interpreting this trial from the registry record is the absence of numerical primary-outcome findings. The endpoint is defined, but group means, standard deviations, treatment contrasts, confidence intervals, and p-values are not reported. The record therefore does not allow assessment of the magnitude, direction, or precision of the IOP changes.

The endpoint spans several follow-up visits and measurement times. The statistical approach to these repeated measurements is not reported, nor is it clear whether the record intended separate comparisons or a combined analysis. The registry lists no primary-outcome analyses. Multiplicity procedures and the statistical analysis plan are also not reported in the registry record.

The primary analysis population is described as mITT according to treatment received, but the record does not provide the number analyzed by group or visit. Missing-data methods, reasons for missing measurements, and sensitivity analyses are not reported. The available study-eye definition ends before explaining how selection was handled if both eyes qualified.

Additional design details are not reported, including the randomization method, allocation concealment procedures, and which people were masked. The registry identifies the study as double-masked, but does not describe how masking was implemented. These omissions prevent a full appraisal of the conduct and analysis.

The reported safety summaries are descriptive. Statistical comparisons and confidence intervals are not reported, and the record does not supply context for assigning the listed serious-term percentages to treatment groups. These limitations do not establish that the study was conducted improperly; they identify what cannot be evaluated from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) — NCT05335122.
• Registry record last updated 2026-09-03; status last verified 2026-08.
• Results first posted 2026-09-03.
• 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.

18. Record Summary

The registry record describes a completed, randomized, double-masked, parallel-group Phase 2 trial sponsored by Ocular Therapeutix, Inc. Enrollment was 83. The study compared low-dose and high-dose OTX-TIC travoprost intracameral implants with Durysta, a bimatoprost intracameral implant 10 µg, in people with open-angle glaucoma or ocular hypertension.

The primary outcome was change from baseline in study-eye IOP at Week 2, Week 6, and Week 12, with measurements at 8 AM, 10 AM, and 4 PM. The analysis population was described as mITT according to treatment received. Numerical results for the primary outcome and details of the statistical analysis are not reported in the registry record.

Safety summaries report serious and other adverse events by group and list no deaths. These counts are descriptive; comparative uncertainty estimates are not reported. The registry identifies the trial’s design and outcome, but does not provide enough primary-outcome results to assess treatment-effect magnitude or precision.