Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Xalatan
* Drug: Monoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18years Danish speaking Open angle glaucoma or ocular hypertension Average intraocular pressure equal to or above 22 mmHg 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BAK-preserved<br>Xalatan eye drop | Drug: Xalatan<br>* Eye drop<br>* Other names: BAK-preserved latanoprost;|
| Active Comparator: Preservative-free<br>Monoprost eye drop | Drug: Monoprost<br>* Eye drop<br>* Other names: Preservative-free latanoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goblet cell density | Change in goblet cell density | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | change in intraocular pressure | 3 months | 
| Ocular surface | change in oxford scheme grading | 3 months | 
| 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 |