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A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC high dose Travoprost Intracameral Implant
Durysta, Bimatoprost Intracameral Implant 10 µg
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Are 18 years of age or older at the time of screening
  • Provide written informed consent and are able to comply with all study requirements
  • Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk
  • Have a negative pregnancy test result for women of childbearing potential at Baseline
  • Have a documented diagnosis of OHT, or OAG in the study eye

Exclusion Criteria:

  • Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes)
  • Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study
  • Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

Sites / Locations

  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutiux, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix IncRecruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutiux, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix IncRecruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

OTX-TIC Low Dose

OTX-TIC High Dose

Durysta

Arm Description

Travoprost Intracameral Implant low dose

Travoprost Intracameral Implant high dose

Bimatoprost Intracameral Implant 10 µg

Outcomes

Primary Outcome Measures

Efficacy Outcome: IOP changes from Baseline
IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye

Secondary Outcome Measures

Full Information

First Posted
April 12, 2022
Last Updated
May 22, 2023
Sponsor
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05335122
Brief Title
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Official Title
A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

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 efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Detailed Description
This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking
ParticipantOutcomes Assessor
Masking Description
Sponsor, Study Coordinator, Investigator
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTX-TIC Low Dose
Arm Type
Experimental
Arm Description
Travoprost Intracameral Implant low dose
Arm Title
OTX-TIC High Dose
Arm Type
Experimental
Arm Description
Travoprost Intracameral Implant high dose
Arm Title
Durysta
Arm Type
Active Comparator
Arm Description
Bimatoprost Intracameral Implant 10 µg
Intervention Type
Drug
Intervention Name(s)
OTX-TIC low dose Travoprost Intracameral Implant
Intervention Description
OTX-TIC implant is injected into the anterior chamber of the eye.
Intervention Type
Drug
Intervention Name(s)
OTX-TIC high dose Travoprost Intracameral Implant
Intervention Description
OTX-TIC implant is injected into the anterior chamber of the eye.
Intervention Type
Drug
Intervention Name(s)
Durysta, Bimatoprost Intracameral Implant 10 µg
Intervention Description
Durysta is injected into the anterior chamber of the eye.
Primary Outcome Measure Information:
Title
Efficacy Outcome: IOP changes from Baseline
Description
IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye
Time Frame
Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are 18 years of age or older at the time of screening Provide written informed consent and are able to comply with all study requirements Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk Have a negative pregnancy test result for women of childbearing potential at Baseline Have a documented diagnosis of OHT, or OAG in the study eye Exclusion Criteria: Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes) Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
781-357-4000
Email
clinicalaffairs@ocutx.com
Facility Information:
Facility Name
Ocular Therapeutix, Inc.
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Ocular Therapeutix, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutiux, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix Inc
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
49085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Troy
State/Province
New York
ZIP/Postal Code
12108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutiux, Inc.
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

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