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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit | |
| Primary | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit | |
| Primary | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit | |
| Other | Number of Participants With Serious Adverse Events | Through study completion, an average of 23 months | Number of Participants with Serious Adverse Events |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit | mmHg | MEAN | |
| PRIMARY | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit | mmHg | MEAN | |
| PRIMARY | Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit | mmHg | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious Adverse Events | Through study completion, an average of 23 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean IOP | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 8AM | 21 | Standard Error 0.2 | mmHg |
| Mean IOP | Placebo Vehicle (PV) | 8AM | 22.9 | Standard Error 0.2 | mmHg |
| Mean IOP | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 10AM | 20.2 | Standard Error 0.2 | mmHg |
| Mean IOP | Placebo Vehicle (PV) | 10AM | 21.9 | Standard Error 0.2 | mmHg |
| Mean IOP | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 4PM | 19.5 | Standard Error 0.2 | mmHg |
| Mean IOP | Placebo Vehicle (PV) | 4PM | 21.5 | Standard Error 0.2 | mmHg |
| Mean IOP | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 8AM | 21.9 | Standard Error 0.2 | mmHg |
| Mean IOP | Placebo Vehicle (PV) | 8AM | 26.9 | Standard Error 0.3 | mmHg |
| Mean IOP | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 10AM | 25.1 | Standard Error 0.2 | mmHg |
| Mean IOP | Placebo Vehicle (PV) | 10AM | 25 | Standard Error 0.2 | mmHg |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OTX-TP | 348 | |
| Overall Study | STARTED | Placebo Vehicle (PV) | 217 | |
| Overall Study | COMPLETED | OTX-TP | 343 | |
| Overall Study | COMPLETED | Placebo Vehicle (PV) | 211 | |
| Overall Study | NOT COMPLETED | OTX-TP | 5 | |
| Overall Study | NOT COMPLETED | Placebo Vehicle (PV) | 6 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adverse Event | General disorders | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 132 | 348 | |
| other | Adverse Event | General disorders | Placebo Vehicle (PV) | 65 | 217 | |
| serious | Serious Adverse Event | Nervous system disorders | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 2 | 348 | |
| serious | Serious Adverse Event | Nervous system disorders | Placebo Vehicle (PV) | 0 | 217 | |
| serious | Serious Adverse Event | Infections and infestations | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 1 | 348 | |
| serious | Serious Adverse Event | Infections and infestations | Placebo Vehicle (PV) | 2 | 217 | |
| serious | Serious Adverse Event | Cardiac disorders | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 1 | 348 | |
| serious | Serious Adverse Event | Cardiac disorders | Placebo Vehicle (PV) | 1 | 217 | |
| serious | Serious Adverse Event | Respiratory, thoracic and mediastinal disorders | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 0 | 348 | |
| serious | Serious Adverse Event | Respiratory, thoracic and mediastinal disorders | Placebo Vehicle (PV) | 1 | 217 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 1 | 348 |
| Total, all-cause mortality | Placebo Vehicle (PV) | 0 | 217 |
| Total, other adverse events | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 132 | 348 |
| Total, other adverse events | Placebo Vehicle (PV) | 65 | 217 |
| Total, serious adverse events | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | 7 | 348 |
| Total, serious adverse events | Placebo Vehicle (PV) | 6 | 217 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): deaths from any cause | Trial comparisons |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): Number of Participants With Serious Adverse Events | Trial comparisons |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot vs Placebo Vehicle (PV): serious adverse events | Trial 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.
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