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

Sponsor

Ocular Therapeutix, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04747977

Collaborator

(none)

166

Enrollment

Locations

Arms

7.3

Actual Duration (Months)

11.1

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: OTX-DED Drug: OTX-DED Drug: OTX-DED	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the studyParallel: Participants are assigned to one of two or more groups in parallel for the duration of the study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Feb 12, 2021

Actual Primary Completion Date :

Aug 11, 2021

Actual Study Completion Date :

Sep 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-DED 0.2mg Approximately 50 subjects	Drug: OTX-DED 0.2mg dexamethasone ophthalmic insert
Experimental: OTX-DED 0.3mg Approximately 50 subjects	Drug: OTX-DED 0.3mg dexamethasone ophthalmic insert
Placebo Comparator: Hydrogel Vehicle (HV) Approximately 50 subjects	Drug: OTX-DED Hydrogel vehicle ophthalmic insert

Arm

Intervention/Treatment

Experimental: OTX-DED 0.2mg

Approximately 50 subjects

Drug: OTX-DED

0.2mg dexamethasone ophthalmic insert

Experimental: OTX-DED 0.3mg

Approximately 50 subjects

Drug: OTX-DED

0.3mg dexamethasone ophthalmic insert

Placebo Comparator: Hydrogel Vehicle (HV)

Approximately 50 subjects

Drug: OTX-DED

Hydrogel vehicle ophthalmic insert

Outcome Measures

Primary Outcome Measures

Change of bulbar conjunctival hyperemia from baseline by central reading center photographic assessment [15 days post treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocular Therapeutix	Inglewood	California	United States	90301
2	Ocular Therapeutix, Inc	Mission Hills	California	United States	91345
3	Ocular Therapeutix, Inc.	Newport Beach	California	United States	92663
4	Ocular Therapeutix, Inc.	Santa Ana	California	United States	92705
5	Ocular Therapeutix, Inc.	Delray Beach	Florida	United States	33484
6	Ocular Therapeutix, Inc.	Largo	Florida	United States	33773
7	Ocular Therapeutix	Warrenville	Illinois	United States	60555
8	Ocular Therapeutix, Inc.	Indianapolis	Indiana	United States	46260
9	Ocular Therapeutix	Kansas City	Missouri	United States	64111
10	Ocular Therapeutix, Inc.	Saint Louis	Missouri	United States	63131
11	Ocular Therapeutix	Poughkeepsie	New York	United States	12603
12	Ocular Therapeutix, Inc.	Raleigh	North Carolina	United States	27603
13	Ocular Therapeutix, Inc.	Cranberry Township	Pennsylvania	United States	16066
14	Ocular Therapeutix, Inc.	Memphis	Tennessee	United States	38119
15	Ocular Therapeutix, Inc.	League City	Texas	United States	77573

Sponsors and Collaborators

Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ocular Therapeutix, Inc.

ClinicalTrials.gov Identifier:

NCT04747977

Other Study ID Numbers:

OTX-DED-2020-201

First Posted:

Feb 10, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ocular Therapeutix, Inc.

dexamethasone ophthalmic insert

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Study Results

No Results Posted as of Dec 17, 2021