NCT02736175

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 11, 2017

Completed
Last Updated

November 13, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

February 10, 2016

Results QC Date

September 13, 2017

Last Update Submit

October 11, 2017

Conditions

Post-Surgical Ocular PainPost-Surgical Ocular Inflammation

Outcome Measures

Primary Outcomes (2)

  • Absence of Anterior Chamber Inflammation

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

    Day 14

  • Absence of Ocular Pain

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

    Day 8

Study Arms (2)

OTX-DP

EXPERIMENTAL

OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Drug: Dexamethasone

PV

PLACEBO COMPARATOR

PV (placebo drug delivery vehicle)

Other: Placebo Vehicle

Interventions

DexamethasoneDRUG
OTX-DP
Placebo VehicleOTHER
PV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Jamie L. Metzinger, Medical Affairs
Organization
Ocular Therapeutix
jmetzinger@ocutx.com
781-357-4000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

April 13, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

November 13, 2017

Results First Posted

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share