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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01979913
Other study ID # OPHT-260213
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2013
Last updated April 21, 2015
Start date October 2013
Est. completion date September 2014

Study information

Verified date April 2015
Source Ordination Dr. Hommer
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health Care
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbeha¨ltnis


Locations

Country Name City State
Austria Ordination Dr. Hommer Vienna

Sponsors (1)

Lead Sponsor Collaborator
Dr. Anton Hommer

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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