Actively Recruiting
Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells in Glaucoma and Ocular Hypertension
Led by Rigshospitalet, Denmark · Updated on 2023-11-18
28
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
L
Laboratoires Thea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of two types of eye drops—benzalkonium-chloride (BAK) preserved and preservative-free (PF)—on the conjunctival goblet cells in adults with open angle glaucoma or ocular hypertension. This randomized, investigator-blind interventional study aims to understand how these eye drops influence goblet cell density and intraocular pressure. Participants will use two different eye drops: Xalatan, which contains benzalkonium-chloride as a preservative, and Monoprost, which is preservative-free. Each participant applies one type of eye drop to one eye and the other type to the opposite eye for a duration of three months. The assignment of which eye receives which treatment is randomized to compare their effects directly. During the study, conjunctival prints will be taken before and after treatment to assess goblet cell density changes. Researchers will also measure intraocular pressure, ocular surface condition, mucin content, cytokines in the tear film, and evaluate ocular surface disease index at the three-month mark. Participants will be monitored throughout the study, which is expected to last around three months, to evaluate these outcomes and any effects related to the treatments.
CONDITIONS
Brief Title
Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Danish speaking
- Diagnosis of open angle glaucoma or ocular hypertension
- Average intraocular pressure equal to or above 22 mmHg
You will not qualify if you...
- History of significant eye disease other than open angle glaucoma or ocular hypertension
- Treatment with steroids within the last 3 months
- Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease, or autoimmune diseases unless well treated or not needing treatment
- Pregnant or breastfeeding
- Women using unsafe contraception
- Allergy to trial medication
- Inability to cooperate in eye examination
- Presence of ocular surface defects
- Need for polytherapy in glaucoma treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants apply benzalkonium-chloride preserved eye drops in one eye and preservative-free eye drops in the other eye for 3 months as randomized.
Baseline visit and 1 follow-up visit at 3 months
Trial Site Locations
Total: 2 locations
1
Department of ophthalmology, rigshospitalet.glostrup
Glostrup Municipality, Danmark, Denmark, 2600
Not Yet Recruiting
2
Department of drug design and pharmacology, University of Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
A
Anne Nagstrup, MD
M
Miriam Kolko, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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