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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001642-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Laboratoires Thea | INDUSTRY |
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a randomized, investigator-blind, interventinal study will compare the effect of benzalkonium-chloride (BAK) preserved and preservative-free (PF) eye drops on conjunctival goblet cells.
The investigators will conduct a randomized, investigator-blind, interventinal study on 28 subjects. Each subject will apply a benzalkonium-chloride (BAK) preserved eye drop (Xalatan) in one eye and a preservative-free (PF) eye drop (Monoprost) in the other for 3 months. Which eye gets which treatment is randomized. Before and after treatment a conjunctival print will be made and the effect of the eye drops on goblet cell density will be evaluated along with effect on the intraocular pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAK-preserved | Active Comparator | Xalatan eye drop |
|
| Preservative-free | Active Comparator | Monoprost eye drop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalatan | Drug | Eye drop |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Goblet cell density | Change in goblet cell density | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | change in intraocular pressure | 3 months |
| Ocular surface | change in oxford scheme grading | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension d. treatment with steroids within the last 3 months from inclusion e. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination k. ocular surface defects l. need for polytherapy in glaucoma treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Nagstrup, MD | Contact | +4522334504 | anne.hedengran.nagstrup@regionh.dk | |
| Miriam Kolko, MD, PhD | Contact | miriamk@sund.ku.dk |
| Name | Affiliation | Role |
|---|---|---|
| Miriam Kolko, MD, PhD | Department of ophthalmology, rigshospitalet-Glostrup | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ophthalmology, rigshospitalet.glostrup | Not yet recruiting | Glostrup Municipality | Danmark | 2600 | Denmark |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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each subject will be treated with a BAK-preserved eye drop in one eye and PF-eye drops in the other eye for 3 months.
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| Monoprost | Drug | Eye drop |
|
|
| Mucin content in tear film | change in mucin concentration | 3 months |
| Cytokines in tear film | change in concentration of detectable interleukins e.g. interleukin 6 | 3 months |
| Ocular surface disease index evaluation | Change in OSDI | 3 months |
| Department of drug design and pharmacology, University of Copenhagen | Recruiting | Copenhagen | 2100 | Denmark |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |