NCT04362670

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2020

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

April 16, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

November 14, 2023

Completed
Last Updated

November 14, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

April 16, 2020

Results QC Date

October 27, 2022

Last Update Submit

October 24, 2023

Conditions

Dry Eye Disease

Keywords

CyclosporineIntracanalicular insert

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With At Least One (1) Treatment Emergent Adverse Event

    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

    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

Study Arms (5)

OTX-CSI-Cohort 1

EXPERIMENTAL

Formulation 2A-.36 mg

Drug: OTX-CSI

OTX-CSI-Cohort 2

EXPERIMENTAL

Formulation 1- .36 mg

Drug: OTX-CSI

HV

PLACEBO COMPARATOR

Cohort 2: Formulation 2B

Other: Placebo Vehicle

OTX-CSI- Cohort 2

EXPERIMENTAL

Formulation 2A- .36 mg

Drug: OTX-CSI

HV-2

PLACEBO COMPARATOR

Cohort 2: Formulation 3

Other: Placebo Vehicle

Interventions

OTX-CSIDRUG

OTX-CSI intracanalicular insert

OTX-CSI- Cohort 2OTX-CSI-Cohort 1OTX-CSI-Cohort 2
Placebo VehicleOTHER

Hydrogel Vehicle intracanalicular insert

HVHV-2

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 ≥ 30.

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, Inc.

Garden Grove, California, 92843, United States

Location

Ocular Therapeutix, Inc.

Inglewood, California, 90301, United States

Location

Ocular Therapeutix, Inc.

Mission Hills, California, 91345, United States

Location

Ocular Therapeutix, Inc.

Delray Beach, Florida, 33484, United States

Location

Ocular Therapeutix, Inc.

Largo, Florida, 33773, United States

Location

Ocular Therapeutix, Inc.

Lake Villa, Illinois, 60046, United States

Location

Ocular Therapeutix, Inc.

Kansas City, Missouri, 64111, United States

Location

Ocular Therapeutix, Inc

St Louis, Missouri, 63128, United States

Location

Ocular Therapeutix

St Louis, Missouri, 63131, United States

Location

Ocular Therapeutix, Inc.

Cleveland, Ohio, 44115, 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.

El Paso, Texas, 79902, United States

Location

Ocular Therapeutix

Lakeway, Texas, 78738, United States

Location

Ocular Therapeutix, Inc.

Murray, Utah, 84107, 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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 27, 2020

Study Start

April 23, 2020

Primary Completion

August 11, 2021

Study Completion

August 11, 2021

Last Updated

November 14, 2023

Results First Posted

November 14, 2023

Record last verified: 2023-10

Locations

US(15)