A Phase 4 interventional study of Xalatan and Monoprost in Glaucoma and Ocular Hypertension, sponsored by Rigshospitalet, Denmark. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment
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.
649 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's planned enrollment of 28 is below the median of 120 across 510 interventional studies indexed under Ocular Hypertension.
Browse Ocular Hypertension studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Xalatan eye drop
Drug: Xalatan
Monoprost eye drop
Drug: Monoprost
Eye drop
Also known as: BAK-preserved latanoprost
Eye drop
Also known as: Preservative-free latanoprost
Goblet cell density
Change in goblet cell density
Time frame: 3 months
Intraocular pressure
change in intraocular pressure
Time frame: 3 months
Ocular surface
change in oxford scheme grading
Time frame: 3 months
Mucin content in tear film
change in mucin concentration
Time frame: 3 months
Cytokines in tear film
change in concentration of detectable interleukins e.g. interleukin 6
Time frame: 3 months
Ocular surface disease index evaluation
Change in OSDI
Time frame: 3 months
Plan to share: No
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Rigshospitalet, Denmark