NCT02062905

Brief Summary

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 9, 2016

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

February 11, 2014

Results QC Date

February 29, 2016

Last Update Submit

August 28, 2019

Conditions

Chronic Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ocular Itching

    Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)

    14 days post insertion

Secondary Outcomes (1)

  • Conjunctival Redness

    14 days post insertion

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 VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
  • Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

You may not qualify if:

  • History of ocular surgical intervention within the past 3 months
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the following disallowed medications during the period indicated

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
Director, Clinical Affairs
Organization
Ocular Therapeutix, Inc.
dmulani@ocutx.com
781-357-4000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
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 11, 2014

First Posted

February 14, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

September 11, 2019

Results First Posted

May 9, 2016

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share