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NCT Number: NCT04957329

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of ophthalmology, rigshospitalet.glostrup, Glostrup Municipality, Danmark, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18years
  • Danish speaking
  • Open angle glaucoma or ocular hypertension
  • 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

Treatment and study plan

Xalatan

Drug

Eye drop

Other names: BAK-preserved latanoprost

Monoprost

Drug

Eye drop

Other names: Preservative-free latanoprost

Primary outcomes

  1. Goblet cell density

    Time frame: 3 months

    Change in goblet cell density

Secondary outcomes

  1. Intraocular pressure

    Time frame: 3 months

    change in intraocular pressure

  2. Ocular surface

    Time frame: 3 months

    change in oxford scheme grading

  3. Mucin content in tear film

    Time frame: 3 months

    change in mucin concentration

  4. Cytokines in tear film

    Time frame: 3 months

    change in concentration of detectable interleukins e.g. interleukin 6

  5. Ocular surface disease index evaluation

    Time frame: 3 months

    Change in OSDI

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Nagstrup, MD

CONTACT

[email protected]

+4522334504

Miriam Kolko, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Laboratoires Thea

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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