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

Sponsor

Ordination Dr. Hommer (Other)

Overall Status

Completed

CT.gov ID

NCT03204487

Collaborator

(none)

Enrollment

Location

Arm

13.7

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: Tafluprost 15µg/ml	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 10, 2016

Actual Primary Completion Date :

Apr 25, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Tear film thickness [Change from baseline tear film thickness at 4 and 12 weeks]
Measurement of tear film thickness using OCT

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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