Glaucoma, Ocular Hypertension
Conditions
Brief summary
Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension
Interventions
DRUGtravoprost 0.004% and brinzolamide 1%
Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)
DRUGfixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension * Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM * Stable visual field in last 6 months * 6 weeks wash out from previous topical medications
Exclusion criteria
* Age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra Ocular Pressure (IOP) | Baseline, end of each period (week 8, week 16, week 24) | Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points |
Countries
Italy
Participant flow
Recruitment details
46 patients suffering from POAG or ocular hypertension, with an intraocular pressure that was insufficiently controlled were recruited.
Pre-assignment details
Subjects meeting the inclusion/exclusion criteria were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 22 | 3 / 24 |
| serious Total, serious adverse events | 0 / 22 | 2 / 24 |
Outcome results
Primary
Intra Ocular Pressure (IOP)
Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points
Time frame: Baseline, end of each period (week 8, week 16, week 24)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crossover Group ABB | Intra Ocular Pressure (IOP) | Week 8 | 179.20 mm Hg (millimeters mercury)*week | Standard Deviation 25.42 |
| Crossover Group ABB | Intra Ocular Pressure (IOP) | Week 16 | 188.82 mm Hg (millimeters mercury)*week | Standard Deviation 32.05 |
| Crossover Group ABB | Intra Ocular Pressure (IOP) | Week 24 | 201.50 mm Hg (millimeters mercury)*week | Standard Deviation 41.01 |
| Crossover Group BAA | Intra Ocular Pressure (IOP) | Week 8 | 191.89 mm Hg (millimeters mercury)*week | Standard Deviation 52.59 |
| Crossover Group BAA | Intra Ocular Pressure (IOP) | Week 16 | 196.26 mm Hg (millimeters mercury)*week | Standard Deviation 59.07 |
| Crossover Group BAA | Intra Ocular Pressure (IOP) | Week 24 | 191.93 mm Hg (millimeters mercury)*week | Standard Deviation 41.39 |