search
Back to results

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTX-DED
OTX-DED
OTX-DED
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dexamethasone ophthalmic insert

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dry Eye Disease diagnosis
  • VAS eye dryness severity score ≥ 40.

Exclusion Criteria:

  • Are unwilling to discontinue use of contact lenses
  • Are unwilling to withhold use of artificial tears.

Sites / Locations

  • Ocular Therapeutix
  • Ocular Therapeutix, Inc
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

OTX-DED 0.2mg

OTX-DED 0.3mg

Hydrogel Vehicle (HV)

Arm Description

Approximately 50 subjects

Approximately 50 subjects

Approximately 50 subjects

Outcomes

Primary Outcome Measures

Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
January 30, 2023
Sponsor
Ocular Therapeutix, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04747977
Brief Title
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Official Title
A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of OTX-DED (Dexamethasone Intracanalicular Ophthalmic Insert) for the Short-Term Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
Detailed Description
Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dexamethasone ophthalmic insert

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTX-DED 0.2mg
Arm Type
Experimental
Arm Description
Approximately 50 subjects
Arm Title
OTX-DED 0.3mg
Arm Type
Experimental
Arm Description
Approximately 50 subjects
Arm Title
Hydrogel Vehicle (HV)
Arm Type
Placebo Comparator
Arm Description
Approximately 50 subjects
Intervention Type
Drug
Intervention Name(s)
OTX-DED
Intervention Description
0.2mg dexamethasone ophthalmic insert
Intervention Type
Drug
Intervention Name(s)
OTX-DED
Intervention Description
0.3mg dexamethasone ophthalmic insert
Intervention Type
Drug
Intervention Name(s)
OTX-DED
Intervention Description
Hydrogel vehicle ophthalmic insert
Primary Outcome Measure Information:
Title
Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
Description
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia [evaluated by the central reading center (CRC)] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
Time Frame
Change from baseline (Day 1) at Visit 4 (Day 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dry Eye Disease diagnosis VAS eye dryness severity score ≥ 40. Exclusion Criteria: Are unwilling to discontinue use of contact lenses Are unwilling to withhold use of artificial tears.
Facility Information:
Facility Name
Ocular Therapeutix
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Ocular Therapeutix, Inc
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Ocular Therapeutix
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Ocular Therapeutix
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ocular Therapeutix
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States

12. IPD Sharing Statement

Learn more about this trial

To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

We'll reach out to this number within 24 hrs