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

Phase 4

Recruiting

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Xalatan; Drug: Monoprost

• Registration Number: NCT04957329
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-30
• Study First Posted: 2021-07-12
• Study Start: 2021-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Age >18years
2. Danish speaking
3. Open angle glaucoma or ocular hypertension
4. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAK-preserved	Xalatan	Xalatan eye drop
Preservative-free	Monoprost	Monoprost eye drop

Primary Outcome Measures

Name	Time	Method
Goblet cell density	3 months	Change in goblet cell density

Secondary Outcome Measures

Name	Time	Method
Ocular surface disease index evaluation	3 months	Change in OSDI
Ocular surface	3 months	change in oxford scheme grading
Intraocular pressure	3 months	change in intraocular pressure
Cytokines in tear film	3 months	change in concentration of detectable interleukins e.g. interleukin 6
Mucin content in tear film	3 months	change in mucin concentration

Trial Locations

Locations (2)

Department of ophthalmology, rigshospitalet.glostrup; 🇩🇰 Glostrup, Danmark, Denmark

Department of drug design and pharmacology, University of Copenhagen; 🇩🇰 Copenhagen, Denmark