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

Last updated: May 8, 2023
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

4

Condition

Ocular Hypertension

Glaucoma

Treatment

Monoprost

Xalatan

Clinical Study ID

NCT04957329
WP3
2019-001642-18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria: a. history of significant eye diseae (including okular trauma) other than open angleglaucoma and ocular hypertension d. treatment with steroids within the last 3 months frominclusion e. Significant untreated systemic disease such as hypertension, heart failure,diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reasonfor exclusion if they are well treated or does not need treatment g. pregnant or breastfeeding h. women using unsafe anticonception i. allergy towards trial medication j.patients who cannot cooperate in eye examination k. ocular surface defects l. need forpolytherapy in glaucoma treatment

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Monoprost
Phase: 4
Study Start date:
September 01, 2021
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • Department of ophthalmology, rigshospitalet.glostrup

    Glostrup, Danmark 2600
    Denmark

    Site Not Available

  • Department of drug design and pharmacology, University of Copenhagen

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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