Glaucoma, Intraocular Pressure, Ocular Hypertension
Conditions
Brief summary
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension
Detailed description
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP). Design Prospective, open-label experimental study. Setting Single tertiary ophthalmic clinic. Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years). Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions. Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.
Interventions
DRUG0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* primary open-angle glaucoma or ocular hypertension
Exclusion criteria
* Women of childbearing potential previous glaucoma surgery presence of other eye disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Intraocular Pressure (IOP) Change | 4 weeks | Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline. |
Countries
United States
Participant flow
Recruitment details
Experimental subjects were recruited consecutively from patients with diagnosed bilateral primary open angle glaucoma or ocular hypertension at the Hamilton Glaucoma Center of the University of California, San Diego.
Pre-assignment details
Subjects who smoked, had previous glaucoma surgery in either eye, had a history of ocular trauma or a sleep disorder, or had an irregular sleep schedule were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 0.01% Bimatoprost 0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | 0.01% Bimatoprost |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Nocturnal Intraocular Pressure (IOP) Change
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.01% Bimatoprost | Nocturnal Intraocular Pressure (IOP) Change | -2.6 mmHg | Standard Deviation 2.8 |