Glaucoma
Conditions
Keywords
glaucoma, diurnal, intraocular pressure
Brief summary
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt
Detailed description
Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.
Interventions
DRUGCosopt
Cosopt twice daily in both eyes
Sponsors
West Virginia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bilateral open-angle glaucoma
Exclusion criteria
* contraindications to Cosopt * pathology affecting tonometry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diurnal Intraocular Pressure Control | 12 months | Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12) |
Participant flow
Recruitment details
10 subjects enrolled from WVU Eye Institute between April 2006 and April 2008
Pre-assignment details
No patients excluded at any time
Participants by arm
| Arm | Count |
|---|---|
| Cosopt Cosopt BID OU | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Time constraints | 2 |
Baseline characteristics
| Characteristic | Cosopt |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Diurnal Intraocular Pressure Control
Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)
Time frame: 12 months
Population: Selected by level funding available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cosopt | Diurnal Intraocular Pressure Control | -4.4 millimeters of mercury | Standard Deviation 2 |