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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
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* Drug: Tafluprost 15µg/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tear film thickness, ocular surface disease, OCT