Ocular Hypertension, Open Angle Glaucoma
Conditions
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).
Interventions
DRUGOTX-TIC
OTX-TIC implant is injection in the anterior chamber of the eye
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Treatment Emergent Adverse Events | Through study completion, 6 months | All adverse events will be captured throughout the study |
| Efficacy Outcome | Diurnal IOP [12 Week Visit] | IOP measurements at 8 am |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-TIC-Cohort 1 15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 5 |
| OTX-TIC-Cohort 2 26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 4 |
| OTX-TIC-Cohort 3 15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 5 |
| OTX-TIC-Cohort 4 5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye | 5 |
| Total | 19 |
Baseline characteristics
| Characteristic | OTX-TIC-Cohort 1 | OTX-TIC-Cohort 2 | OTX-TIC-Cohort 3 | OTX-TIC-Cohort 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 4 Participants | 1 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 3 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 2 Participants | 2 Participants | 5 Participants | 14 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 5 participants | 5 participants | 19 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 2 / 4 | 3 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Efficacy Outcome
IOP measurements at 8 am
Time frame: Diurnal IOP [12 Week Visit]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OTX-TIC-Cohort 1 | Efficacy Outcome | -5.6 mmHg mean IOP change at wk12 from bln | Standard Deviation 2.58 |
| OTX-TIC-Cohort 2 | Efficacy Outcome | -7.0 mmHg mean IOP change at wk12 from bln | Standard Deviation 3.27 |
| OTX-TIC-Cohort 3 | Efficacy Outcome | -3.0 mmHg mean IOP change at wk12 from bln | Standard Deviation 14.4 |
| OTX-TIC-Cohort 4 | Efficacy Outcome | -7.4 mmHg mean IOP change at wk12 from bln | Standard Deviation 4.76 |
Primary
Ocular Treatment Emergent Adverse Events
All adverse events will be captured throughout the study
Time frame: Through study completion, 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OTX-TIC-Cohort 1 | Ocular Treatment Emergent Adverse Events | 9 Number of Treatment-Emergent Events |
| OTX-TIC-Cohort 2 | Ocular Treatment Emergent Adverse Events | 7 Number of Treatment-Emergent Events |
| OTX-TIC-Cohort 3 | Ocular Treatment Emergent Adverse Events | 9 Number of Treatment-Emergent Events |
| OTX-TIC-Cohort 4 | Ocular Treatment Emergent Adverse Events | 1 Number of Treatment-Emergent Events |