Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
Interventions
DRUGHigh Dose Device
inserted for 14 days
DRUGLow Dose Device
inserted for 14 days
DEVICEPlacebo Device
inserted for 14 days
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 * must have 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 | Description |
|---|---|---|
| Visual Acuity - Right Eye | at 14 days | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
| Visual Acuity - Left Eye | at 14 days | This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal. |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular Pressure (IOP) | from baseline to 14 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, high dose | 16 |
| Low Dose Bimatoprost Punctal Plug punctal plug with bimatoprost, low dose | 15 |
| Placebo punctal plug without bimatoprost | 20 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | failed plug insertion | 3 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | High Dose Bimatoprost Punctal Plug | Low Dose Bimatoprost Punctal Plug | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 13.4 | 64.6 years STANDARD_DEVIATION 12.9 | 64.5 years STANDARD_DEVIATION 10.6 | 65.2 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 13 Participants | 31 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 7 Participants | 20 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 | 13 / 16 | 11 / 15 | 11 / 20 |
| serious Total, serious adverse events | 1 / 16 | 0 / 15 | 0 / 20 |
Outcome results
Primary
Visual Acuity - Left Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: at 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Bimatoprost Punctal Plug | Visual Acuity - Left Eye | -0.011 logMARs | Standard Deviation 0.081 |
| Low Dose Bimatoprost Punctal Plug | Visual Acuity - Left Eye | -0.008 logMARs | Standard Deviation 0.101 |
| Placebo | Visual Acuity - Left Eye | -0.019 logMARs | Standard Deviation 0.044 |
Primary
Visual Acuity - Right Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Time frame: at 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Bimatoprost Punctal Plug | Visual Acuity - Right Eye | 0.015 logMAR units | Standard Deviation 0.046 |
| Low Dose Bimatoprost Punctal Plug | Visual Acuity - Right Eye | -0.044 logMAR units | Standard Deviation 0.092 |
| Placebo | Visual Acuity - Right Eye | -0.012 logMAR units | Standard Deviation 0.044 |
Secondary
Intraocular Pressure (IOP)
Time frame: from baseline to 14 days
Population: The analysis population includes all subjects with a plug insertion that completed the study per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Bimatoprost Punctal Plug | Intraocular Pressure (IOP) | -1.9 mmHg | Standard Deviation 2.3 |
| Low Dose Bimatoprost Punctal Plug | Intraocular Pressure (IOP) | -2.2 mmHg | Standard Deviation 3.5 |
| Placebo | Intraocular Pressure (IOP) | -1.3 mmHg | Standard Deviation 3.6 |
Comparison: The alternative hypothesis was that the high dose was different from the placebo.p-value: 0.9737ANCOVA
Comparison: The alternative hypothesis is that the low dose was different from placebo.p-value: 0.4711ANCOVA