Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01979913
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Anton Hommer, Ordination Dr. Hommer

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Tafluprost

Arm Intervention/treatment
Experimental: Patients with POAG or OHT
Patients with primary open angle glaucoma or ocular hypertension
Drug: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis
Other Name: Tafluprost




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979913


Locations
Layout table for location information
Austria
Ordination Dr. Hommer
Vienna, Austria, 1080
Sponsors and Collaborators
Dr. Anton Hommer
Layout table for additonal information
Responsible Party: Dr. Anton Hommer, Dr. med. univ., Ordination Dr. Hommer
ClinicalTrials.gov Identifier: NCT01979913    
Other Study ID Numbers: OPHT-260213
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015
Keywords provided by Dr. Anton Hommer, Ordination Dr. Hommer:
Primary Open Angle Glaucoma
Ocular Hypertension
Tafluprost
Saflutan
Intraocular pressure
Preservative free
Single dose unit
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases