Open-angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
Interventions
DRUGHigh Dose Drug Device
device inserted for 4 days
DRUGLow Dose Drug Device
device inserted for 4 days
DRUGPlacebo Device
device inserted for 4 days
one drop in each eye on one day only
Sponsors
Vistakon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or woman 21 years of age or greater * Open angle glaucoma or ocular hypertension * Corrected visual acuity in each eye of 20/200 or better
Exclusion criteria
* Previous glaucoma intraocular surgery or refractive surgery * Planned contact lens use during the study * Clinically significant ocular or systemic disease that might interfere with the study * Use of chronic corticosteroids by any route
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Intraocular Pressure at Day 1 | Baseline to Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in Intraocular Pressure at Day 2 | Baseline to Day 2 |
| Mean Change in Intraocular Pressure at Day 3 | Baseline to Day 3 |
| Mean Change in Intraocular Pressure at Day 4 | Baseline to Day 4 |
| Mean Change in Intraocular Pressure at Day 5 | Day 4 to Day 5 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Dose Drug Device/ Bimatoprost 0.03% high dose drug device during first period, bimatoprost 0.03% during second period. | 17 |
| Low Dose Drug Device / Bimatoprost 0.03% low-dose drug device during first period, bimatoprost 0.03% during second period. | 12 |
| Placebo Device / Bimatoprost 0.03% placebo device during first period, bimatoprost 0.03% during second period. | 18 |
| Total | 47 |
Baseline characteristics
| Characteristic | High Dose Drug Device/ Bimatoprost 0.03% | Low Dose Drug Device / Bimatoprost 0.03% | Placebo Device / Bimatoprost 0.03% | Total |
|---|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9.78 | 66.3 years STANDARD_DEVIATION 11.37 | 63.1 years STANDARD_DEVIATION 9.07 | 63.4 years STANDARD_DEVIATION 8.68 |
| Region of Enrollment United States | 17 participants | 12 participants | 18 participants | 47 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 17 | 7 / 12 | 8 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 12 | 0 / 18 |
Outcome results
Primary
Mean Change in Intraocular Pressure at Day 1
Time frame: Baseline to Day 1
Population: per-protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Drug Device/ Bimatoprost 0.03% | Mean Change in Intraocular Pressure at Day 1 | -4.16 mmHg | Standard Deviation 3.409 |
| Low Dose Drug Device / Bimatoprost 0.03% | Mean Change in Intraocular Pressure at Day 1 | -4.57 mmHg | Standard Deviation 3.645 |
| Placebo Device / Bimatoprost 0.03% | Mean Change in Intraocular Pressure at Day 1 | -0.60 mmHg | Standard Deviation 2.331 |
Secondary
Mean Change in Intraocular Pressure at Day 2
Time frame: Baseline to Day 2
Secondary
Mean Change in Intraocular Pressure at Day 3
Time frame: Baseline to Day 3
Secondary
Mean Change in Intraocular Pressure at Day 4
Time frame: Baseline to Day 4
Secondary
Mean Change in Intraocular Pressure at Day 5
Time frame: Day 4 to Day 5