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

NCT01979913 | Completed Phase 4 DMC

• 1 other identifier: OPHT-260213
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

Primary Open Angle Glaucoma; Ocular Hypertension; Tafluprost; Saflutan; Intraocular pressure; Preservative free; Single dose unit

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with POAG or OHT

EXPERIMENTAL

Patients with primary open angle glaucoma or ocular hypertension

Drug: Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis

Interventions

Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis DRUG

Also known as: Tafluprost

Patients with POAG or OHT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Anton Hommer: lead

Study Sites (1)

Ordination Dr. Hommer

Vienna, Vienna, 1080, Austria

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

tafluprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

AU (1)