Open Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension
Detailed description
This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.
Interventions
DRUGTravoprost
OTHERPlacebo Vehicle
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession * IOP is currently controlled as assessed by the Investigator
Exclusion criteria
* Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge * A history of an inadequate response or no response to topical prostaglandin * Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean IOP | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | Through study completion, an average of 23 months | Number of Participants with Serious Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot Three hundred forty eight (348) subjects were randomized to OTX-TP | 348 |
| Placebo Vehicle (PV) Two hundred seventeen (217) subjects were randomized to the PV. | 217 |
| Total | 565 |
Baseline characteristics
| Characteristic | OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Placebo Vehicle (PV) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 188 Participants | 126 Participants | 314 Participants |
| Age, Categorical Between 18 and 65 years | 160 Participants | 91 Participants | 251 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized African American | 84 Participants | 48 Participants | 132 Participants |
| Race/Ethnicity, Customized Caucasian | 247 Participants | 159 Participants | 406 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 10 Participants | 27 Participants |
| Region of Enrollment United States | 348 participants | 217 participants | 565 participants |
| Sex: Female, Male Female | 185 Participants | 135 Participants | 320 Participants |
| Sex: Female, Male Male | 163 Participants | 82 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 348 | 0 / 217 |
| other Total, other adverse events | 132 / 348 | 65 / 217 |
| serious Total, serious adverse events | 7 / 348 | 6 / 217 |
Outcome results
Primary
Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 8AM | 21 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 10AM | 20.2 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 4PM | 19.5 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 8AM | 22.9 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 10AM | 21.9 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 4PM | 21.5 mmHg | Standard Error 0.2 |
Primary
Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 8AM | 21.9 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 10AM | 25.1 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 4PM | 24.8 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 8AM | 26.9 mmHg | Standard Error 0.3 |
| Placebo Vehicle (PV) | Mean IOP | 10AM | 25 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 4PM | 24.6 mmHg | Standard Error 0.2 |
Primary
Mean IOP
Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 8AM | 22.8 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 10AM | 21.7 mmHg | Standard Error 0.2 |
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Mean IOP | 4PM | 21.4 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 4PM | 22.1 mmHg | Standard Error 0.2 |
| Placebo Vehicle (PV) | Mean IOP | 8AM | 23.2 mmHg | Standard Error 0.3 |
| Placebo Vehicle (PV) | Mean IOP | 10AM | 22.5 mmHg | Standard Error 0.2 |
Other Pre-specified
Number of Participants With Serious Adverse Events
Number of Participants with Serious Adverse Events
Time frame: Through study completion, an average of 23 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OTX-TP (Sustained Release Travoprost) Intracanalicular Depot | Number of Participants With Serious Adverse Events | 7 Participants |
| Placebo Vehicle (PV) | Number of Participants With Serious Adverse Events | 6 Participants |