Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

October 24, 2023 updated by: Ocular Therapeutix, Inc.

A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)

To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Garden Grove, California, United States, 92843
        • Ocular Therapeutix, Inc.
      • Inglewood, California, United States, 90301
        • Ocular Therapeutix, Inc.
      • Mission Hills, California, United States, 91345
        • Ocular Therapeutix, Inc.
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Ocular Therapeutix, Inc.
      • Largo, Florida, United States, 33773
        • Ocular Therapeutix, Inc.
    • Illinois
      • Lake Villa, Illinois, United States, 60046
        • Ocular Therapeutix, Inc.
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Ocular Therapeutix, Inc.
      • Saint Louis, Missouri, United States, 63128
        • Ocular Therapeutix, Inc
      • Saint Louis, Missouri, United States, 63131
        • Ocular Therapeutix
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • Ocular Therapeutix, Inc.
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Ocular Therapeutix, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Ocular Therapeutix, Inc.
    • Texas
      • El Paso, Texas, United States, 79902
        • Ocular Therapeutix, Inc.
      • Lakeway, Texas, United States, 78738
        • Ocular Therapeutix
    • Utah
      • Murray, Utah, United States, 84107
        • Ocular Therapeutix, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dry eye disease diagnosis
  • VAS eye dryness severity score ≥ 30.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-CSI-Cohort 1
Formulation 2A-.36 mg
Drug: OTX-CSI
OTX-CSI intracanalicular insert
Experimental: OTX-CSI-Cohort 2
Formulation 1- .36 mg
Drug: OTX-CSI
OTX-CSI intracanalicular insert
Placebo Comparator: HV

Cohort 2:

Formulation 2B
Other: Placebo Vehicle
Hydrogel Vehicle intracanalicular insert
Experimental: OTX-CSI- Cohort 2
Formulation 2A- .36 mg
Drug: OTX-CSI
OTX-CSI intracanalicular insert
Placebo Comparator: HV-2

Cohort 2:

Formulation 3
Other: Placebo Vehicle
Hydrogel Vehicle intracanalicular insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Time Frame: From Screening to Study Exit, approximately 156 days.
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
From Screening to Study Exit, approximately 156 days.
Schirmer Test Score, CFB at Week 12
Time Frame: Change from Baseline at Week 12
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
Change from Baseline at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2020

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

August 11, 2021

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-Protocol-0054

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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