Open-angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension
Interventions
DRUGTravatan
Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
DRUGCosopt
treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)
DRUGPlacebo (Timolol Vehicle)
Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with open-angle glaucoma or ocular hypertension
Exclusion criteria
* By Age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment | At week 0 and week 6 | IOP measured at week 6 minus IOP measured at baseline |
Countries
Portugal
Participant flow
Recruitment details
Recruitment period: from 13-03-2007 to 30-11-2007 Recruitment restarted on 27-03-2008 to 27-05-2008 First patient first visit: 19-03-2007 Last patient last visit: 29-05-2008
Pre-assignment details
After completing the run-in, 8 patients were not randomized: 7 patients did not meet entry criteria and 1 patient was excluded by sponsor's decision.
Participants by arm
| Arm | Count |
|---|---|
| Travatan | 21 |
| Cosopt | 25 |
| Total | 46 |
Baseline characteristics
| Characteristic | Travatan | Cosopt | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 9 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 21 | 3 / 25 |
| serious Total, serious adverse events | 0 / 21 | 1 / 25 |
Outcome results
Primary
Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment
IOP measured at week 6 minus IOP measured at baseline
Time frame: At week 0 and week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Travatan | Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment | -4.57 millimeters mercury (mm Hg) | Standard Deviation 1.62 |
| Cosopt | Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment | -4.08 millimeters mercury (mm Hg) | Standard Deviation 2.5 |