search
Back to results

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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OTX-CSI
Placebo Vehicle
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring Cyclosporine, Intracanalicular 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 ≥ 30.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

OTX-CSI-Cohort 1

OTX-CSI-Cohort 2

HV

OTX-CSI- Cohort 2

HV-2

Arm Description

Formulation 2A-.36 mg

Formulation 1- .36 mg

Cohort 2: Formulation 2B

Formulation 2A- .36 mg

Cohort 2: Formulation 3

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events for each subject
All adverse events will be captured throughout the study
Efficacy outcome measures
Schirmer test

Secondary Outcome Measures

Full Information

First Posted
April 16, 2020
Last Updated
December 14, 2021
Sponsor
Ocular Therapeutix, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04362670
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 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 safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTX-CSI-Cohort 1
Arm Type
Experimental
Arm Description
Formulation 2A-.36 mg
Arm Title
OTX-CSI-Cohort 2
Arm Type
Experimental
Arm Description
Formulation 1- .36 mg
Arm Title
HV
Arm Type
Placebo Comparator
Arm Description
Cohort 2: Formulation 2B
Arm Title
OTX-CSI- Cohort 2
Arm Type
Experimental
Arm Description
Formulation 2A- .36 mg
Arm Title
HV-2
Arm Type
Placebo Comparator
Arm Description
Cohort 2: Formulation 3
Intervention Type
Drug
Intervention Name(s)
OTX-CSI
Intervention Description
OTX-CSI intracanalicular insert
Intervention Type
Other
Intervention Name(s)
Placebo Vehicle
Intervention Description
Hydrogel Vehicle intracanalicular insert
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events for each subject
Description
All adverse events will be captured throughout the study
Time Frame
Through study completion, an average of 1 year
Title
Efficacy outcome measures
Description
Schirmer test
Time Frame
Absolute value and change from baseline at week 12

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 ≥ 30. Exclusion Criteria: Are unwilling to discontinue use of contact lenses Are unwilling to withhold use of artificial tears.
Facility Information:
Facility Name
Ocular Therapeutix, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Ocular Therapeutix, Inc.
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
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, Inc.
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Ocular Therapeutix, Inc.
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
63128
Country
United States
Facility Name
Ocular Therapeutix
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
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
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Ocular Therapeutix
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78738
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs