search
Back to results

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

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

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
  • Have IOP that is currently controlled as assessed by the Investigator
  • Have open, normal appearing anterior chamber angles as determined by gonioscopy

Exclusion Criteria:

  • Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
  • Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

OTX-TIC-Cohort 1

OTX-TIC-Cohort 2

OTX-TIC-Cohort 3

OTX-TIC-Cohort 4

Arm Description

15 µg (formulation1) implant

26 µg (formulation1) implant

15 µg (formulation 2) implant

5 µg (formulation 3) implant

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events for each subject
All adverse events will be captured throughout the study
Efficacy outcome
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome
IOP measurements at 8 am, 10 am, and 4 pm

Secondary Outcome Measures

Full Information

First Posted
March 20, 2020
Last Updated
February 8, 2023
Sponsor
Ocular Therapeutix, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04360174
Brief Title
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Official Title
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
May 24, 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
Yes

5. Study Description

Brief Summary
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed Description
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OTX-TIC-Cohort 1
Arm Type
Experimental
Arm Description
15 µg (formulation1) implant
Arm Title
OTX-TIC-Cohort 2
Arm Type
Experimental
Arm Description
26 µg (formulation1) implant
Arm Title
OTX-TIC-Cohort 3
Arm Type
Experimental
Arm Description
15 µg (formulation 2) implant
Arm Title
OTX-TIC-Cohort 4
Arm Type
Experimental
Arm Description
5 µg (formulation 3) implant
Intervention Type
Drug
Intervention Name(s)
OTX-TIC
Intervention Description
OTX-TIC implant is injection in the anterior chamber of the eye
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, 6 months
Title
Efficacy outcome
Description
IOP measurements at 8 am, 10 am, and 4 pm
Time Frame
Diurnal IOP [Time Frame: 2 Week Visit]
Title
Efficacy outcome
Description
IOP measurements at 8 am, 10 am, and 4 pm
Time Frame
Diurnal IOP [ 6 Week Visit]
Title
Efficacy outcome
Description
IOP measurements at 8 am, 10 am, and 4 pm
Time Frame
Diurnal IOP [12 Week Visit]
Title
Efficacy outcome
Description
IOP measurements at 8 am, 10 am, and 4 pm
Time Frame
Diurnal IOP [4 Months Visit]
Title
Efficacy outcome
Description
IOP measurements at 8 am, 10 am, and 4 pm
Time Frame
Diurnal IOP [6 Months Visit]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma Have IOP that is currently controlled as assessed by the Investigator Have open, normal appearing anterior chamber angles as determined by gonioscopy Exclusion Criteria: Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
Facility Information:
Facility Name
Ocular Therapeutix, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Ocular Therapeutix, Inc
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Ocular Therapeutix, Inc.
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

We'll reach out to this number within 24 hrs