Ocular Hypertension, Primary Open Angle Glaucoma
Conditions
Keywords
Primary Open Angle Glaucoma, Ocular Hypertension, Tafluprost, Saflutan, Intraocular pressure, Preservative free, Single dose unit
Brief summary
Increased intraocular pressure (IOP) has been identified as the most important risk factor for the development and the progression of glaucoma. Data from large interventional studies have shown that a decrease of IOP is associated with a reduced risk of progression of the disease. This underlines the importance of a potent and save IOP lowering therapy. The introduction of preservative free tafluprost offers a new treatment possibility using a potent topical prostaglandin analogue without the disadvantages of a co-administered preservative. The current study seeks to investigate the effect of an 8 week therapy with preservative free tafluprost on intraocular pressure in patients with ocular hypertension or primary open angle glaucoma having an IOP of 30 mmHg or more.
Interventions
DRUGSaflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis
Sponsors
Dr. Anton Hommer
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
* Men and women aged over 18 years * Diagnosed primary open angle glaucoma and an IOP of 30mmHg or more in at least 1 eye at visit 1 at 8 am * Patients with ocular hypertension as defined as an IOP of 30mmHg or more and normal findings in the visual field and the optic nerve head
Exclusion criteria
* Participation in a clinical trial in the 3 weeks before the screening visit * Severe visual field loss as defined as an MD of -15 or worse * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator * Wearing of contact lenses * Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants * Ocular infection * Ocular surgery in the 6 months preceding the study * Pregnancy, planned pregnancy or lactating * Contraindication against the use of topical prostaglandin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 8 weeks | Intraocular pressure will be measured at baseline, after 4 weeks and after 8 weeks at 8:00 am and 6:00 pm on each study day |
Countries
Austria
Outcome results
None listed