Glaucoma, Open-Angle, Ocular Hypertension
Conditions
Keywords
tear film thickness, ocular surface disease, OCT
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.
Interventions
DRUGTafluprost 15µg/ml
Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien)
Sponsors
Ordination Dr. Hommer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film thickness | Change from baseline tear film thickness at 4 and 12 weeks | Measurement of tear film thickness using OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Intraocular pressure (IOP) | Change from baseline IOP at 4 and 12 weeks | Measurement of IOP using Goldmann applanation tonometry |
| 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. |
| Schirmer Test 1 | Change from Schirmer Test 1 at 4 and 12 weeks | Wetting of Schirmer test strips within 5 minutes without topical anaesthesia. |
Countries
Austria
Outcome results
None listed