Trial | NCT01979913  Report issue

Official Title

An Open, Non-randomized Pilot Study on the Effect of Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma With an Uncontrolled Intraocular Pressure of 30 mmHg and More

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tafluprost ...

  • Study Participants

    16
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.
Study Started
Oct 31
2013
Primary Completion
Apr 30
2014
Study Completion
Sep 30
2014
Last Update
Apr 23
2015
Estimate

Drug Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis

  • Other names: Tafluprost

Patients with POAG or OHT Experimental

Patients with primary open angle glaucoma or ocular hypertension

Criteria 

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
No Results Posted