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)
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)
1 other identifier
interventional
83
1 country
30
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Typical duration for phase_2
30 active sites
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
Study Start
First participant enrolled
March 16, 2022
CompletedFirst Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2025
CompletedMarch 21, 2025
March 1, 2025
1.9 years
April 12, 2022
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
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]
Study Arms (3)
OTX-TIC Low Dose
EXPERIMENTALTravoprost Intracameral Implant low dose
OTX-TIC High Dose
EXPERIMENTALTravoprost Intracameral Implant high dose
Durysta
ACTIVE COMPARATORBimatoprost Intracameral Implant 10 µg
Interventions
OTX-TIC implant is injected into the anterior chamber of the eye.
OTX-TIC implant is injected into the anterior chamber of the eye.
Durysta is injected into the anterior chamber of the eye.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Ocular Therapeutix, Inc.
Dothan, Alabama, 36301, United States
Ocular Therapeutix, Inc.
Huntington Beach, California, 92647, United States
Ocular Therapeutix, Inc.
Irvine, California, 92604, United States
Ocular Therapeutix, Inc.
Los Angeles, California, 90013, United States
Ocular Therapeutix, Inc.
Pasadena, California, 91107, United States
Ocular Therapeutix, Inc.
Petaluma, California, 94954, United States
Ocular Therapeutix, Inc.
Redlands, California, 92373, United States
Ocular Therapeutix, Inc.
Torrance, California, 90505, United States
Ocular Therapeutix, Inc.
Clearwater, Florida, 33761, United States
Ocular Therapeutiux, Inc.
Delray Beach, Florida, 33484, United States
Ocular Therapeutix, Inc.
Fort Myers, Florida, 33901, United States
Ocular Therapeutix, Inc.
Roswell, Georgia, 30076, United States
Ocular Therapeutix, Inc.
Rock Island, Illinois, 61201, United States
Ocular Therapeutix Inc
Carmel, Indiana, 46032, United States
Ocular Therapeutix, Inc.
Saint Joseph, Michigan, 49085, United States
Ocular Therapeutix, Inc.
Saint Joseph, Missouri, 49085, United States
Ocular Therapeutix Inc.
St Louis, Missouri, 63110, United States
Ocular Therapeutix, Inc.
Dover, New Jersey, 07801, United States
Ocular Therapeutix, Inc.
Troy, New York, 12108, United States
Ocular Therapeutix, Inc.
Durham, North Carolina, 27710, United States
Ocular Therapeutiux, Inc.
Fargo, North Dakota, 58103, United States
Ocular Therapeutix, Inc.
Cleveland, Ohio, 44106, United States
Ocular Therapeutix Inc
Oklahoma City, Oklahoma, 73112, United States
Ocular Therapeutix, Inc.
Cranberry Township, Pennsylvania, 16066, United States
Ocular Therapeutix, Inc.
Philadelphia, Pennsylvania, 19107, United States
Ocular Therapeutix, Inc.
Austin, Texas, 78701, United States
Ocular Therapeutix, Inc.
Dallas, Texas, 75231, United States
Ocular Therapeutix, Inc.
El Paso, Texas, 79902, United States
Ocular Therapeutix, Inc.
Houston, Texas, 77030, United States
Ocular Therapeutix, Inc.
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Sponsor, Study Coordinator, Investigator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 19, 2022
Study Start
March 16, 2022
Primary Completion
January 24, 2024
Study Completion
January 24, 2025
Last Updated
March 21, 2025
Record last verified: 2025-03