A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness

An Open, Non-randomized Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma on Tear Film Thickness

Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma with a prevalence of 50% or more. The percentage of affected patients appears to increase with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and more anti-glaucoma drugs without preservatives entered the market.

To prove that switching from preserved to unpreserved antiglaucoma medication improves the signs and symptom of OSD is, however, not easy. This is on the one hand related to the physiological variability of these parameters over time and on the other hand to the poor association between signs and symptoms. Recently, a new method for measuring tear film thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been introduced. Using this method, it has been shown that there is a correlation between reduced TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are on preserved prostaglandin formulations to preservative free tafluprost may be associated with an increase in TFT.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Intervention / Treatment: Drug: Tafluprost 15µg/ml

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1080
    • Ordination Dr. Hommer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged over 18 years
• Diagnosed primary open angle glaucoma treated with preserved prostaglandins for at least 6 months OR
• Patients with ocular hypertension treated with preserved prostaglandins for at least 6 months
• IOP ≤ 21 mmHg in the study eye at the screening examination (under treatment)
• Mean TFT at the screening visit ≤ 6µm in the study eye
• At least 2 symptoms of dry eye syndrome in the study eye (itching, stinging, blurred vision, foreign body sensation, debris, conjunctival redness) since at least one month
• Tear break up time ≤ 10sec

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 in the study eye
• 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
• Sjögren's syndrome
• Stevens-Johnson syndrome
• Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
• Presence or history of allergic conjunctivitis
• Treatment with corticosteroids in the 4 weeks preceding the study
• 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 (except laser trabeculoplasty)
• Pregnancy, planned pregnancy or lactating
• Contraindication against the use of topical prostaglandin therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with glaucoma or ocular hypertension	Drug: Tafluprost 15µg/ml; Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear film thickness	Measurement of tear film thickness using OCT	Change from baseline tear film thickness at 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP)	Measurement of IOP using Goldmann applanation tonometry	Change from baseline IOP at 4 and 12 weeks
Ocular Surface Disease Index (OSDI)	Subjective symptom questionnaire	Change from baseline OSDI at 4 and 12 weeks
Dry-Eye Related Quality of Life Score (DEQS)	Subjective symptom questionnaire	Change from baseline DEQS at 4 and 12 weeks
Tear Break Up Time (BUT)	Assessment of BUT in seconds using fluorescein eye drops at the slit lamp.	Change from baseline BUT at 4 and 12 weeks
Schirmer Test 1	Wetting of Schirmer test strips within 5 minutes without topical anaesthesia.	Change from Schirmer Test 1 at 4 and 12 weeks
Tear film osmolarity	Tear film osmolarity will be assessed using the TearLab Osmolarity Test.	Change from baseline tear film osmolarity at 4 and 12 weeks
Corneal fluorescein staining	Corneal fluorescein staining will be assessed after instillation of fluorescein eye drops at the slit lamp.	Change from baseline corneal fluorescein staining at 4 and 12 weeks

Collaborators and Investigators

• Sponsor: Ordination Dr. Hommer

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2016
• Primary Completion (Actual): April 25, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: OCT; tear film thickness; ocular surface disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: HOM1-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No