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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with glaucoma or ocular hypertension | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafluprost 15µg/ml | Drug | Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordination Dr. Hommer | Vienna | 1080 | Austria |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
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| 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 |