Glaucoma, Open-angle, Ocular Hypertension
Conditions
Keywords
Glaucoma, POAG, OAG, OHT
Brief summary
Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.
Interventions
DRUGTravatan
Travoprost (0.004%) 1 drop each eye once daily
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients of any race and either sex with chronic angle-closure glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure | At 5 years. | Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited in ophthalmic clinics, academic and civil hospitals from September 24, 2002. Last patient completed the study on March 23, 2009.
Participants by arm
| Arm | Count |
|---|---|
| Travatan Travoprost (0.004%) | 502 |
| Total | 502 |
Baseline characteristics
| Characteristic | Travatan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 265 Participants |
| Age, Categorical Between 18 and 65 years | 237 Participants |
| Sex: Female, Male Female | 281 Participants |
| Sex: Female, Male Male | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 304 / 502 |
| serious Total, serious adverse events | 99 / 502 |
Outcome results
Primary
Mean Intraocular Pressure
Mean IOP for the patient's worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken. All IOP measurements were performed with a Goldmann applanation tonometer.
Time frame: At 5 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travatan | Mean Intraocular Pressure | 16.5 millimeters mercury (mm Hg) | Standard Deviation 2.6 |