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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

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:

Age >18years
Danish speaking
Open angle glaucoma or ocular hypertension
Average intraocular pressure equal to or above 22 mmHg based on 3 measurements on each eye

Exclusion Criteria:

history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension
Pressure difference equal to or above 4 mmHg between eyes
corneal thickness <450μm or >600μm
treatment with steroids within the last 3 months from inclusion
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
smoker at inclusion
pregnant or breast feeding
women using unsafe anticonception
allergy towards trial medication
patients who cannot cooperate in eye examination
ocular surface defects
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

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

NCT ID

NCT04957329

First Posted

June 22, 2021

Last Updated

May 8, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

Laboratoires Thea

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

anne.hedengran.nagstrup@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Miriam Kolko, MD, PhD

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

anne.hedengran.nagstrup@regionh.dk

First Name & Middle Initial & Last Name & Degree

Miriam Kolko, MD, Phd

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

Learn more about this trial

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

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