Clinical trial NCT05335122: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-19
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Efficacy Outcome: IOP changes from Baseline
timeFrame: 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]
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Ocular Therapeutix, Inc.
state: Alabama
city: Huntington Beach
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Irvine
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Los Angeles
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Pasadena
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Petaluma
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Redlands
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Torrance
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Clearwater
country: United States
facility: Ocular Therapeutix, Inc.
state: Florida
city: Delray Beach
country: United States
facility: Ocular Therapeutiux, Inc.
state: Florida
city: Fort Myers
country: United States
facility: Ocular Therapeutix, Inc.
state: Florida
city: Roswell
country: United States
facility: Ocular Therapeutix, Inc.
state: Georgia
city: Rock Island
country: United States
facility: Ocular Therapeutix, Inc.
state: Illinois
city: Carmel
country: United States
facility: Ocular Therapeutix Inc
state: Indiana
city: Saint Joseph
country: United States
facility: Ocular Therapeutix, Inc.
state: Michigan
city: Saint Joseph
country: United States
facility: Ocular Therapeutix, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Ocular Therapeutix Inc.
state: Missouri
city: Dover
country: United States
facility: Ocular Therapeutix, Inc.
state: New Jersey
city: Troy
country: United States
facility: Ocular Therapeutix, Inc.
state: New York
city: Durham
country: United States
facility: Ocular Therapeutix, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Ocular Therapeutiux, Inc.
state: North Dakota
city: Cleveland
country: United States
facility: Ocular Therapeutix, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Ocular Therapeutix Inc
state: Oklahoma
city: Cranberry Township
country: United States
facility: Ocular Therapeutix, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Ocular Therapeutix, Inc.
state: Pennsylvania
city: Austin
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: Dallas
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: El Paso
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: Houston
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: Kenosha
country: United States
facility: Ocular Therapeutix, Inc.
state: Wisconsin
Study officials:
References: