Ocular Hypertension, Open-Angle Glaucoma
Conditions
Brief summary
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
Interventions
DRUGbimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%
1 drop in eye(s) every evening
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician) * Patient is having both eyes treated
Exclusion criteria
* Contraindications per product labelling will apply. * Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Baseline, 1 Year | Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumigan® bimatoprost 0.03% | 364 |
| Travatan® travoprost 0.004% | 370 |
| Xalatan® latanoprost 0.005% | 365 |
| Total | 1,099 |
Baseline characteristics
| Characteristic | Lumigan® | Travatan® | Xalatan® | Total |
|---|---|---|---|---|
| Age Continuous | 65.5 years | 67.0 years | 67.0 years | 67.0 years |
| Sex: Female, Male Female | 210 Participants | 206 Participants | 201 Participants | 617 Participants |
| Sex: Female, Male Male | 154 Participants | 164 Participants | 164 Participants | 482 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 364 | 0 / 370 | 0 / 365 |
| serious Total, serious adverse events | 5 / 364 | 2 / 370 | 6 / 365 |
Outcome results
Primary
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).
Time frame: Baseline, 1 Year
Population: Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lumigan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Baseline | 20.8 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Lumigan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from Baseline at 1 Year | -4.8 Millimeters of mercury (mmHg) | Standard Deviation 3.3 |
| Travatan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Baseline | 20.3 Millimeters of mercury (mmHg) | Standard Deviation 5 |
| Travatan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from Baseline at 1 Year | -4.3 Millimeters of mercury (mmHg) | Standard Deviation 2.7 |
| Xalatan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Baseline | 20.6 Millimeters of mercury (mmHg) | Standard Deviation 5.2 |
| Xalatan® | Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year | Change from Baseline at 1 Year | -4.3 Millimeters of mercury (mmHg) | Standard Deviation 2.9 |