Trial · NCT02736175

OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

NCT02736175, Phase 3, Completed, Ocular Therapeutix, Inc.; results first posted 2017-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery. Trials, record NCT02736175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02736175

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Trial

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

Title: OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
NCT number: NCT02736175
Status: Completed
Phases: Phase 3
Enrollment: 438 participants, actual
Lead sponsor: Ocular Therapeutix, Inc.
Conditions: Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
Interventions: Dexamethasone, Placebo Vehicle
First posted: 2016-04-13
Last updated: 2017-11-13
Results first posted: 2017-10-11

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Absence of Anterior Chamber Inflammation	Day 14	Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
Primary	Absence of Ocular Pain	Day 8	Absence of pain (i.e., score of '0') in the study eye at Day 8

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absence of Anterior Chamber Inflammation	Day 14	ITT LOCF (last observation carried forward)	percentage of total participants	NUMBER
PRIMARY	Absence of Ocular Pain	Day 8	ITT LOCF (last observation carried forward)	percentage of total participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
Absence of Anterior Chamber Inflammation	OTX-DP	52.3	percentage of total participants
Absence of Anterior Chamber Inflammation	Placebo Vehicle	31.1	percentage of total participants
Absence of Ocular Pain	OTX-DP	79.6	percentage of total participants
Absence of Ocular Pain	Placebo Vehicle	61.3	percentage of total participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	OTX-DP	216
Overall Study	STARTED	Placebo Vehicle	222
Overall Study	COMPLETED	OTX-DP	214
Overall Study	COMPLETED	Placebo Vehicle	221
Overall Study	NOT COMPLETED	OTX-DP	2
Overall Study	NOT COMPLETED	Placebo Vehicle	1

Source ClinicalTrials.gov

Adverse events12

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 Events	General disorders	OTX-DP	63	216	91
other	Adverse Events	General disorders	Placebo Vehicle	86	221	109
serious	Retinal detachment	Eye disorders	OTX-DP	1	216
serious	Retinal detachment	Eye disorders	Placebo Vehicle	0	221
serious	Cardiac failure acute	Cardiac disorders	OTX-DP	1	216
serious	Cardiac failure acute	Cardiac disorders	Placebo Vehicle	0	221
serious	Lower gastrointestinal hemorrhage	Gastrointestinal disorders	OTX-DP	1	216
serious	Lower gastrointestinal hemorrhage	Gastrointestinal disorders	Placebo Vehicle	0	221
serious	Nephrolithiasis	Renal and urinary disorders	OTX-DP	0	216
serious	Nephrolithiasis	Renal and urinary disorders	Placebo Vehicle	1	221

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OTX-DP	0	216
Total, all-cause mortality	Placebo Vehicle	0	221
Total, other adverse events	OTX-DP	63	216
Total, other adverse events	Placebo Vehicle	86	221
Total, serious adverse events	OTX-DP	3	216
Total, serious adverse events	Placebo Vehicle	2	221

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 comparisons2

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

Comparison	Source
OTX-DP vs Placebo Vehicle: deaths from any cause	Trial comparisons
OTX-DP vs Placebo Vehicle: 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.

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/NCT02736175

GET https://conductscience.org/api/trials/v1/NCT02736175/registered

API reference For AI assistants