NCT04747977

Brief Summary

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

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

First Submitted

Initial submission to the registry

February 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 22, 2023

Completed
Last Updated

February 22, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

February 4, 2021

Results QC Date

November 4, 2022

Last Update Submit

January 30, 2023

Conditions

Dry Eye

Keywords

dexamethasone ophthalmic insert

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline (Day 1) at Visit 4 (Day 15)

Study Arms (3)

OTX-DED 0.2mg

EXPERIMENTAL

Approximately 50 subjects

Drug: OTX-DED

OTX-DED 0.3mg

EXPERIMENTAL

Approximately 50 subjects

Drug: OTX-DED

Hydrogel Vehicle (HV)

PLACEBO COMPARATOR

Approximately 50 subjects

Drug: OTX-DED

Interventions

OTX-DEDDRUG

0.2mg dexamethasone ophthalmic insert

OTX-DED 0.2mg

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Ocular Therapeutix

Inglewood, California, 90301, United States

Location

Ocular Therapeutix, Inc

Mission Hills, California, 91345, United States

Location

Ocular Therapeutix, Inc.

Newport Beach, California, 92663, United States

Location

Ocular Therapeutix, Inc.

Santa Ana, California, 92705, United States

Location

Ocular Therapeutix, Inc.

Delray Beach, Florida, 33484, United States

Location

Ocular Therapeutix, Inc.

Largo, Florida, 33773, United States

Location

Ocular Therapeutix

Warrenville, Illinois, 60555, United States

Location

Ocular Therapeutix, Inc.

Indianapolis, Indiana, 46260, United States

Location

Ocular Therapeutix

Kansas City, Missouri, 64111, United States

Location

Ocular Therapeutix, Inc.

St Louis, Missouri, 63131, United States

Location

Ocular Therapeutix

Poughkeepsie, New York, 12603, United States

Location

Ocular Therapeutix, Inc.

Raleigh, North Carolina, 27603, United States

Location

Ocular Therapeutix, Inc.

Cranberry Township, Pennsylvania, 16066, United States

Location

Ocular Therapeutix, Inc.

Memphis, Tennessee, 38119, United States

Location

Ocular Therapeutix, Inc.

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Clinical Project Manager
Organization
Ocular Therapeutix
clinicalaffairs@ocutx.com
781-357-4000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 10, 2021

Study Start

February 12, 2021

Primary Completion

August 11, 2021

Study Completion

September 22, 2021

Last Updated

February 22, 2023

Results First Posted

February 22, 2023

Record last verified: 2023-01

Locations

US(15)