Xalatan
DrugEye drop
Other names: BAK-preserved latanoprost
NCT Number: NCT04957329
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Department of ophthalmology, rigshospitalet.glostrup, Glostrup Municipality, Danmark, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Eye drop
Other names: BAK-preserved latanoprost
Eye drop
Other names: Preservative-free latanoprost
Time frame: 3 months
Change in goblet cell density
Time frame: 3 months
change in intraocular pressure
Time frame: 3 months
change in oxford scheme grading
Time frame: 3 months
change in mucin concentration
Time frame: 3 months
change in concentration of detectable interleukins e.g. interleukin 6
Time frame: 3 months
Change in OSDI
Contact information is provided by the study sponsor or research team.
Anne Nagstrup, MD
CONTACT
Miriam Kolko, MD, PhD
CONTACT
Rigshospitalet, Denmark
Other
Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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