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

November 15, 2023 updated by: Anne Hedengran Nagstrup, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of drug design and pharmacology, University of Copenhagen
        • Contact:
          • Anne Nagstrup, MD
        • Contact:
          • Miriam Kolko, MD, PhD
        • Principal Investigator:
          • Miriam Kolko, MD, PhD
        • Sub-Investigator:
          • Anne Nafstrup, MD
    • Danmark
      • Glostrup, Danmark, Denmark, 2600
        • Not yet recruiting
        • Department of ophthalmology, rigshospitalet.glostrup
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miriam Kolko
        • Sub-Investigator:
          • Anne Nagstrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BAK-preserved
Xalatan eye drop
Drug: Xalatan
Eye drop
Other Names:
  • BAK-preserved latanoprost
Active Comparator: Preservative-free
Monoprost eye drop
Drug: Monoprost
Eye drop
Other Names:
  • Preservative-free latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goblet cell density
Time Frame: 3 months
Change in goblet cell density
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Laboratoires Thea

Investigators

  • Principal Investigator: Miriam Kolko, MD, PhD, Department of Ophthalmology, Rigshospitalet-Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 30, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP3
  • 2019-001642-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe