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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with POAG or OHT<br>Patients with primary open angle glaucoma or ocular hypertension | Drug: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis<br> <br> * Other names: Tafluprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Open Angle Glaucoma, Ocular Hypertension, Tafluprost, Saflutan, Intraocular pressure, Preservative free, Single dose unit