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Trial · NCT02914509

Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

NCT02914509, Phase 3, Completed, Ocular Therapeutix, Inc.; results first posted 2021-10-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT. Trials, record NCT02914509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914509

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
NCT number
NCT02914509
Status
Completed
Phases
Phase 3
Enrollment
565 participants, actual
Lead sponsor
Ocular Therapeutix, Inc.
Conditions
Open Angle Glaucoma, Ocular Hypertension
Interventions
Travoprost, Placebo Vehicle
First posted
2016-09-26
Last updated
2021-10-11
Results first posted
2021-10-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean IOPMean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
PrimaryMean IOPMean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
PrimaryMean IOPMean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
OtherNumber of Participants With Serious Adverse EventsThrough study completion, an average of 23 monthsNumber of Participants with Serious Adverse Events

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean IOPMean IOP at 8AM, 10AM, and 4PM at the 2 Week VisitmmHgMEAN
PRIMARYMean IOPMean IOP at 8AM, 10AM, and 4PM at the 6 Week VisitmmHgMEAN
PRIMARYMean IOPMean IOP at 8AM, 10AM, and 4PM at the 12 Week VisitmmHgMEAN
OTHER_PRE_SPECIFIEDNumber of Participants With Serious Adverse EventsThrough study completion, an average of 23 monthsParticipantsCOUNT_OF_PARTICIPANTS

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Mean IOPOTX-TP (Sustained Release Travoprost) Intracanalicular Depot8AM21Standard Error 0.2mmHg
Mean IOPPlacebo Vehicle (PV)8AM22.9Standard Error 0.2mmHg
Mean IOPOTX-TP (Sustained Release Travoprost) Intracanalicular Depot10AM20.2Standard Error 0.2mmHg
Mean IOPPlacebo Vehicle (PV)10AM21.9Standard Error 0.2mmHg
Mean IOPOTX-TP (Sustained Release Travoprost) Intracanalicular Depot4PM19.5Standard Error 0.2mmHg
Mean IOPPlacebo Vehicle (PV)4PM21.5Standard Error 0.2mmHg
Mean IOPOTX-TP (Sustained Release Travoprost) Intracanalicular Depot8AM21.9Standard Error 0.2mmHg
Mean IOPPlacebo Vehicle (PV)8AM26.9Standard Error 0.3mmHg
Mean IOPOTX-TP (Sustained Release Travoprost) Intracanalicular Depot10AM25.1Standard Error 0.2mmHg
Mean IOPPlacebo Vehicle (PV)10AM25Standard Error 0.2mmHg

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOTX-TP348
Overall StudySTARTEDPlacebo Vehicle (PV)217
Overall StudyCOMPLETEDOTX-TP343
Overall StudyCOMPLETEDPlacebo Vehicle (PV)211
Overall StudyNOT COMPLETEDOTX-TP5
Overall StudyNOT COMPLETEDPlacebo Vehicle (PV)6

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAdverse EventGeneral disordersOTX-TP (Sustained Release Travoprost) Intracanalicular Depot132348
otherAdverse EventGeneral disordersPlacebo Vehicle (PV)65217
seriousSerious Adverse EventNervous system disordersOTX-TP (Sustained Release Travoprost) Intracanalicular Depot2348
seriousSerious Adverse EventNervous system disordersPlacebo Vehicle (PV)0217
seriousSerious Adverse EventInfections and infestationsOTX-TP (Sustained Release Travoprost) Intracanalicular Depot1348
seriousSerious Adverse EventInfections and infestationsPlacebo Vehicle (PV)2217
seriousSerious Adverse EventCardiac disordersOTX-TP (Sustained Release Travoprost) Intracanalicular Depot1348
seriousSerious Adverse EventCardiac disordersPlacebo Vehicle (PV)1217
seriousSerious Adverse EventRespiratory, thoracic and mediastinal disordersOTX-TP (Sustained Release Travoprost) Intracanalicular Depot0348
seriousSerious Adverse EventRespiratory, thoracic and mediastinal disordersPlacebo Vehicle (PV)1217

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityOTX-TP (Sustained Release Travoprost) Intracanalicular Depot1348
Total, all-cause mortalityPlacebo Vehicle (PV)0217
Total, other adverse eventsOTX-TP (Sustained Release Travoprost) Intracanalicular Depot132348
Total, other adverse eventsPlacebo Vehicle (PV)65217
Total, serious adverse eventsOTX-TP (Sustained Release Travoprost) Intracanalicular Depot7348
Total, serious adverse eventsPlacebo Vehicle (PV)6217

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): deaths from any causeTrial comparisons
OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): Number of Participants With Serious Adverse EventsTrial comparisons
OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02914509

GET https://conductscience.org/api/trials/v1/NCT02914509/registered