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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Xalatan
Monoprost
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of ophthalmology, rigshospitalet.glostrup
  • Department of drug design and pharmacology, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

BAK-preserved

Preservative-free

Arm Description

Xalatan eye drop

Monoprost eye drop

Outcomes

Primary Outcome Measures

Goblet cell density
Change in goblet cell density

Secondary Outcome Measures

Intraocular pressure
change in intraocular pressure
Ocular surface
change in oxford scheme grading
Mucin content in tear film
change in mucin concentration
Cytokines in tear film
change in concentration of detectable interleukins e.g. interleukin 6
Ocular surface disease index evaluation
Change in OSDI

Full Information

First Posted
June 22, 2021
Last Updated
May 8, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Laboratoires Thea
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1. Study Identification

Unique Protocol Identification Number
NCT04957329
Brief Title
Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
Official Title
Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Laboratoires Thea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BAK-preserved
Arm Type
Active Comparator
Arm Description
Xalatan eye drop
Arm Title
Preservative-free
Arm Type
Active Comparator
Arm Description
Monoprost eye drop
Intervention Type
Drug
Intervention Name(s)
Xalatan
Other Intervention Name(s)
BAK-preserved latanoprost
Intervention Description
Eye drop
Intervention Type
Drug
Intervention Name(s)
Monoprost
Other Intervention Name(s)
Preservative-free latanoprost
Intervention Description
Eye drop
Primary Outcome Measure Information:
Title
Goblet cell density
Description
Change in goblet cell density
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intraocular pressure
Description
change in intraocular pressure
Time Frame
3 months
Title
Ocular surface
Description
change in oxford scheme grading
Time Frame
3 months
Title
Mucin content in tear film
Description
change in mucin concentration
Time Frame
3 months
Title
Cytokines in tear film
Description
change in concentration of detectable interleukins e.g. interleukin 6
Time Frame
3 months
Title
Ocular surface disease index evaluation
Description
Change in OSDI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Nagstrup, MD
Phone
+4522334504
Email
anne.hedengran.nagstrup@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Kolko, MD, PhD
Email
miriamk@sund.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Kolko, MD, PhD
Organizational Affiliation
Department of ophthalmology, rigshospitalet-Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of ophthalmology, rigshospitalet.glostrup
City
Glostrup
State/Province
Danmark
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Nagstrup, MD
Phone
22334504
Email
anne.hedengran.nagstrup@regionh.dk
First Name & Middle Initial & Last Name & Degree
Miriam Kolko, MD, Phd
Email
miriamk@sund.ku.dk
First Name & Middle Initial & Last Name & Degree
Miriam Kolko
First Name & Middle Initial & Last Name & Degree
Anne Nagstrup
Facility Name
Department of drug design and pharmacology, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Nagstrup, MD
First Name & Middle Initial & Last Name & Degree
Miriam Kolko, MD, PhD
First Name & Middle Initial & Last Name & Degree
Miriam Kolko, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anne Nafstrup, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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