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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957329
• Other study ID #: WP3
• Secondary ID: 2019-001642-18
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Anne Nagstrup, MD
• Phone: +4522334504
• Email: anne.hedengran.nagstrup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Xalatan
Eye drop
• Monoprost
Eye drop

Locations

Country	Name	City	State
Denmark	Department of drug design and pharmacology, University of Copenhagen	Copenhagen
Denmark	Department of ophthalmology, rigshospitalet.glostrup	Glostrup	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Laboratoires Thea

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Goblet cell density	Change in goblet cell density	3 months
Secondary	Intraocular pressure	change in intraocular pressure	3 months
Secondary	Ocular surface	change in oxford scheme grading	3 months
Secondary	Mucin content in tear film	change in mucin concentration	3 months
Secondary	Cytokines in tear film	change in concentration of detectable interleukins e.g. interleukin 6	3 months
Secondary	Ocular surface disease index evaluation	Change in OSDI	3 months