Ocular Hypertension, Open Angle Glaucoma
Conditions
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.
Interventions
DRUGOTX-TIC low dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
DRUGOTX-TIC high dose Travoprost Intracameral Implant
OTX-TIC implant is injected into the anterior chamber of the eye.
Durysta is injected into the anterior chamber of the eye.
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sponsor, Study Coordinator, Investigator
Intervention model description
Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP Changes From Baseline in the Study Eye | Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM) | IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 46 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 64.3 years STANDARD_DEVIATION 10.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 32 | 0 / 34 |
| other Total, other adverse events | 12 / 16 | 20 / 32 | 8 / 34 |
| serious Total, serious adverse events | 1 / 16 | 6 / 32 | 4 / 34 |
Outcome results
None listed