CompletedNCT02736175Updated Nov 13, 2017Results posted

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

A Phase 3 interventional study of Dexamethasone and Placebo Vehicle in Post-Surgical Ocular Pain and Post-Surgical Ocular Inflammation, sponsored by Ocular Therapeutix, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-13.

Sponsored by Ocular Therapeutix, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 4 months after the study started (first participant enrolled Oct 2015, registered Feb 2016).

Phase: Phase 3
Study type: Interventional
Enrollment: 438
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Conditions studied

Post-Surgical Ocular Pain
Post-Surgical Ocular Inflammation

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In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 438 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Ocular Therapeutix, Inc. is the lead sponsor of 32 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens
Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion criteria

Exclusion Criteria:

Any intraocular inflammation in the study eye present during the screening slit lamp examination
Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
Any intraocular inflammation in the study eye present during the screening slit lamp examination

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 438 participants (actual)

Study arms

Experimental
OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Drug: Dexamethasone
Placebo comparator
PV
PV (placebo drug delivery vehicle)
Other: Placebo Vehicle

Interventions

DrugDexamethasone
OtherPlacebo Vehicle

What researchers measure

Primary outcomes

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

Results

Posted Oct 11, 2017

Participant flow

Participant flow — Overall Study
Milestone	OTX-DP	Placebo Vehicle
Started	216	222
Completed	214	221
Not completed	2	1

Outcome measures

PrimaryAbsence of Anterior Chamber Inflammation

Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14

Time frame:: Day 14
Reported as:: Number · percentage of total participants

Absence of Anterior Chamber Inflammation
percentage of total participants	OTX-DP	Placebo Vehicle
Absence of Anterior Chamber Inflammation	52.3	31.1

PrimaryAbsence of Ocular Pain

Absence of pain (i.e., score of '0') in the study eye at Day 8

Time frame:: Day 8
Reported as:: Number · percentage of total participants

Absence of Ocular Pain
percentage of total participants	OTX-DP	Placebo Vehicle
Absence of Ocular Pain	79.6	61.3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OTX-DP	0/216 (0%)	3/216 (1.4%)	63/216 (29.2%)
Placebo Vehicle	0/221 (0%)	2/221 (0.9%)	86/221 (38.9%)

Most frequent serious events

Most frequent serious events
Event	OTX-DP	Placebo Vehicle
Retinal detachmentEye disorders	1/216	0/221
Cardiac failure acuteCardiac disorders	1/216	0/221
Lower gastrointestinal hemorrhageGastrointestinal disorders	1/216	0/221
NephrolithiasisRenal and urinary disorders	0/216	1/221
HypoxiaRespiratory, thoracic and mediastinal disorders	0/216	1/221

Most frequent other events

Most frequent other events
Event	OTX-DP	Placebo Vehicle
Adverse EventsGeneral disorders	63/216	86/221

Baseline characteristics

All randomized subjects

Age, Continuous
Age, Continuous(years)	OTX-DP	Placebo Vehicle	Total
Mean	67.3 ± 9.09	68.6 ± 8.37	68.0 ± 8.75

Sex: Female, Male
Sex: Female, Male(Participants)	OTX-DP	Placebo Vehicle	Total
Female	120	130	250
Male	96	92	188

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	OTX-DP	Placebo Vehicle	Total
Hispanic or Latino	37	37	74
Not Hispanic or Latino	179	185	364
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	OTX-DP	Placebo Vehicle	Total
American Indian or Alaska Native	2	2	4
Asian	8	1	9
Native Hawaiian or Other Pacific Islander	1	1	2
Black or African American	28	25	53
White	174	189	363
More than one race	NA	NA	NA
Unknown or Not Reported	3	4	7

Iris Color
Iris Color(Participants)	OTX-DP	Placebo Vehicle	Total
Brown	106	101	207
Blue	61	64	125
Hazel	32	37	69
Green	15	18	33
Gray	2	0	2
Black	0	2	2

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02736175
Lead sponsor: Ocular Therapeutix, Inc.
Responsible party: Sponsor
First posted: Apr 13, 2016
Start date: Oct 2015
Primary completion: May 2016
Completion: Jul 2016
Results posted: Oct 11, 2017
Last update: Nov 13, 2017

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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