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OpenTrials
Completed

NCT Number: NCT01979913

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ordination Dr. Hommer

Vienna, State of Vienna, 1080, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis

Drug

Other names: Tafluprost

Primary outcomes

  1. Intraocular pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr. Anton Hommer

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2013
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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