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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04957329
Collaborator
Laboratoires Thea (Industry)
28
Enrollment
2
Locations
2
Arms
17.9
Anticipated Duration (Months)
14
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
each subject will be treated with a BAK-preserved eye drop in one eye and PF-eye drops in the other eye for 3 months.each subject will be treated with a BAK-preserved eye drop in one eye and PF-eye drops in the other eye for 3 months.
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure [3 months]

      Change in intraocular pressure

    Secondary Outcome Measures

    1. Goblet cell density [3 months]

      change in goblet cell density

    2. Ocular surface [3 months]

      change in oxford scheme grading

    3. Mucin content in tear film [3 months]

      change in mucin concentration

    4. Cytokines in tear film [3 months]

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

    5. Ocular surface disease index evaluation [3 months]

      Change in OSDI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 based on 3 measurements on each eye

    Exclusion Criteria:

    1. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension

    2. Pressure difference equal to or above 4 mmHg between eyes

    3. corneal thickness <450μm or >600μm

    4. treatment with steroids within the last 3 months from inclusion

    5. 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

    6. smoker at inclusion

    7. pregnant or breast feeding

    8. women using unsafe anticonception

    9. allergy towards trial medication

    10. patients who cannot cooperate in eye examination

    11. ocular surface defects

    12. need for polytherapy in glaucoma treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of ophthalmology, rigshospitalet.glostrup Glostrup Danmark Denmark 2600
    2 Department of drug design and pharmacology, University of Copenhagen Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • Laboratoires Thea

    Investigators

    • Principal Investigator: Miriam Kolko, MD, PhD, Department of ophthalmology, rigshospitalet-Glostrup

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anne Hedengran Nagstrup, Department of ophthalmology, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT04957329
    Other Study ID Numbers:
    • WP3
    • 2019-001642-18
    First Posted:
    Jul 12, 2021
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ocular Hypertension
    Latanoprost

    Study Results

    No Results Posted as of Jul 12, 2021