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Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most of these eye drops contain preservatives to allow for the use of multi-dose containers. In the recent years evidence has, however, accumulated that these preservatives may induce ocular surface disease (OSD). This is particularly true for the most widely used preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro and animal studies, evidence from clinical trials is sparse. The only randomized masked study that showed superiority is a pivotal company-sponsored study indicating improved tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops.
The investigators have recently introduced an optical coherence tomography (OCT) technology that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the investigators were able to show that tear film thickness (TFT) is negatively correlated with symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of resolution as also evident from studies after administration of lubricants.
In the present study, the investigators hypothesize that switching glaucoma patients from preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase in TFT as measured with OCT. As a control the investigators will use preserved latanoprost and the study hypothesis will be tested in a randomized, controlled, single-masked parallel group design. TFT is chosen as main outcome variable, standard measures for signs and symptoms of OSD are selected as secondary outcomes. The present study may provide valuable information on the superiority of unpreserved versus preserved therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with glaucoma or ocular hypertension 1 | Experimental | 35 patients with glaucoma or ocular hypertension |
|
| Patients with glaucoma or ocular hypertension 2 | Active Comparator | 35 patients with glaucoma or ocular hypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative-free latanoprost 50µg/ml | Drug |
| ||
| Preserved latanoprost 0.005% |
| Measure | Description | Time Frame |
|---|---|---|
| Tear film thickness measured with high resolution optical coherence tomography (OCT) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break Up Time | 6 months | |
| Tear Film Osmolarity | 6 months | |
| Conjunctival hyperemia score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Garhofer, MD | Contact | +43 1 40400 | 29810 | gerhard.garhoefer@meduniwien.ac.at |
| Katarzyna J Witkowska, MD, Phd | Contact | +43 1 40400 | 29810 | katarzyna.witkowska@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Drug |
|
| 6 months |
| Staining of the cornea with fluorescein according to Oxford scale | 6 months |
| Impression cytology according to Haller-Schober scale 2006 | 6 months |
| Schirmer 1 test | 6 months |
| Ocular Surface Disease Index score | 6 months |