Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Brief summary
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.
Interventions
DRUGXalacom
Sponsors
Pfizer
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
* Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers
Exclusion criteria
* Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of increase of iris pigmentation | — |
| incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin | — |
| occurrence of ocular/periorbital adverse events | — |
| occurrence of serious adverse events. | — |
Countries
Australia, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed