Back to resultsComparison of Two Types of Artificial Tears
Primary Purpose
Dry Eye Disease
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
Inclusion Criteria:
- Dry Eye Severity Level (DESL) 1-3
- Equivalent between-eye DESL
Exclusion Criteria:
- Ocular infection and/or non-linked inflammation
- Corneal pathology (except KSP)
- Corneal refractive surgery or cataract surgery within 6 months prior to the study
Sites / Locations
- The Norwegian Dry Eye ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Thealoz Duo
Hyabak
Arm Description
Thealoz Duo, a combination of trehalose and hyaluronate, will be used on one of the selected eyes of a patient, at least 3 times daily
Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily
Outcomes
Primary Outcome Measures
Subjective dry eye symptoms
McMonnies dry eye questionnaire
Subjective dry eye symptoms
McMonnies dry eye questionnaire
Subjective dry eye symptoms
McMonnies dry eye questionnaire
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Secondary Outcome Measures
Fluorescein tear film break up time
Unit: seconds
Fluorescein tear film break up time
Unit: seconds
Fluorescein tear film break up time
Unit: seconds
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Tear film osmolarity
Unit: Osm/L
Tear film osmolarity
Unit: Osm/L
Tear film osmolarity
Unit: Osm/L
Meibum expressibility
Evaluated by application of light pressure using cotton tips on the central five MGs of the lower eyelid. Expression was graded according to the number of the MGs with meibum secretion under pressure: grade 0: 5 glands; grade 1: 3-4 glands; grade 2: 1-2 glands; grade 3: 0 gland
Meibum expressibility
Evaluated by application of light pressure using cotton tips on the central five MGs of the lower eyelid. Expression was graded according to the number of the MGs with meibum secretion under pressure: grade 0: 5 glands; grade 1: 3-4 glands; grade 2: 1-2 glands; grade 3: 0 gland
Meibomian gland functionality
Meibum expressibility and quality
Meibum quality
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Meibum quality
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Meibum quality
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Patient´s subjective evaluation of preference
Patients will be asked about which artificial tear they prefer
Patient´s subjective evaluation of preference
Patients will be asked about which artificial tear they prefer
Luminex
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Luminex
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Luminex
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Full Information
NCT ID
NCT05356728
First Posted
April 20, 2022
Last Updated
June 27, 2022
Sponsor
The Norwegian Dry Eye Clinic
Collaborators
Laboratoires Thea
1. Study Identification
Unique Protocol Identification Number
NCT05356728
Brief Title
Comparison of Two Types of Artificial Tears
Official Title
Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Norwegian Dry Eye Clinic
Collaborators
Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Hyaluronic acid (HA), a natural component of the tear film, is a well-established active ingredient in artificial tears and has been reported to improve corneal and conjunctival staining in patients with DED. Thealoz Duo (Laboratoires Thea, Clermont Ferrand, France) is a novel artificial tear preparation containing two active ingredients: trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. The purpose of the current study is to investigate the effect of the Hyabak and Thealoz Duo in treatment of DED.
Detailed Description
The patients will be treated with Thealoz Duo (at least 3 times daily) in one eye and with Hyabak (at least 3 times daily) in the other eye, based on randomization table. Both Hyabak and Thealoz Duo are preservative free. The doctors who examine the patients will not get any information about the choice of artificial tears in each eye. Besides the artificial tears, if necessary, the patients will receive other treatments, for instance, steroids, cyclosporine etc., according to their dry eye severity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The doctors who examine the patients will not get any information about the choice of artificial tears in each eye.
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thealoz Duo
Arm Type
Active Comparator
Arm Description
Thealoz Duo, a combination of trehalose and hyaluronate, will be used on one of the selected eyes of a patient, at least 3 times daily
Arm Title
Hyabak
Arm Type
Active Comparator
Arm Description
Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily
Intervention Type
Drug
Intervention Name(s)
Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop
Intervention Description
One of the eyes will be assigned to use Thealoz Duo while the other with Hyabak by using randomisation table
Primary Outcome Measure Information:
Title
Subjective dry eye symptoms
Description
McMonnies dry eye questionnaire
Time Frame
Baseline,
Title
Subjective dry eye symptoms
Description
McMonnies dry eye questionnaire
Time Frame
1 month after treatment is initiated
Title
Subjective dry eye symptoms
Description
McMonnies dry eye questionnaire
Time Frame
3 months after treatment is initiated
Title
Subjective dry eye symptoms
Description
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time Frame
Baseline
Title
Subjective dry eye symptoms
Description
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time Frame
1 month after treatment is initiated
Title
Subjective dry eye symptoms
Description
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time Frame
3 months after treatment is initiated
Secondary Outcome Measure Information:
Title
Fluorescein tear film break up time
Description
Unit: seconds
Time Frame
Baseline
Title
Fluorescein tear film break up time
Description
Unit: seconds
Time Frame
1 month after treatment is initiated
Title
Fluorescein tear film break up time
Description
Unit: seconds
Time Frame
3 months after treatment is initiated
Title
Schirmer test
Description
Without anaesthesia, recorded as mm in length of wetting after 5min
Time Frame
Baseline
Title
Schirmer test
Description
Without anaesthesia, recorded as mm in length of wetting after 5min
Time Frame
1 month after treatment is initiated
Title
Schirmer test
Description
Without anaesthesia, recorded as mm in length of wetting after 5min
Time Frame
3 months after treatment is initiated
Title
Ocular surface staining
Description
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time Frame
Baseline
Title
Ocular surface staining
Description
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time Frame
1 month after treatment is initiated
Title
Ocular surface staining
Description
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time Frame
3 months after treatment is initiated
Title
Tear film osmolarity
Description
Unit: Osm/L
Time Frame
Baseline
Title
Tear film osmolarity
Description
Unit: Osm/L
Time Frame
1 month after treatment is initiated
Title
Tear film osmolarity
Description
Unit: Osm/L
Time Frame
3 month after treatment is initiated
Title
Meibum expressibility
Description
Evaluated by application of light pressure using cotton tips on the central five MGs of the lower eyelid. Expression was graded according to the number of the MGs with meibum secretion under pressure: grade 0: 5 glands; grade 1: 3-4 glands; grade 2: 1-2 glands; grade 3: 0 gland
Time Frame
Baseline
Title
Meibum expressibility
Description
Evaluated by application of light pressure using cotton tips on the central five MGs of the lower eyelid. Expression was graded according to the number of the MGs with meibum secretion under pressure: grade 0: 5 glands; grade 1: 3-4 glands; grade 2: 1-2 glands; grade 3: 0 gland
Time Frame
1 month after treatment is initiated
Title
Meibomian gland functionality
Description
Meibum expressibility and quality
Time Frame
3 months after treatment is initiated
Title
Meibum quality
Description
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Time Frame
Baseline
Title
Meibum quality
Description
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Time Frame
1 month after treatment is initiated
Title
Meibum quality
Description
The quality of the meibum that was secreted from each gland was graded as following: 0, clear; 1, cloudy; 2, cloudy with particles; and 3, toothpaste like. The sum of the score of the central 8 glands in the lower eyelid will be recorded
Time Frame
3 months after treatment is initiated
Title
Patient´s subjective evaluation of preference
Description
Patients will be asked about which artificial tear they prefer
Time Frame
1 month after the treatment is initiated
Title
Patient´s subjective evaluation of preference
Description
Patients will be asked about which artificial tear they prefer
Time Frame
3 months after the treatment is initiated
Title
Luminex
Description
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Time Frame
Baseline
Title
Luminex
Description
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Time Frame
1 month after treatment is initiated
Title
Luminex
Description
A multiplex Luminex® bead-based assay will be used to analyze cytokines from the tear samples. The cytokines to be analysed include 27 different cytokines, including interleukin 1b (IL-1b), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, IL-1 receptor antagonist (IL-1ra), eotaxin, basic fibroblast growth factor (bFGF/FGF2), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), interferon gamma (IFN-γ), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP-1α/CCL3), MIP-1b, platelet-derived growth factor bb (PDGF-BB), regulated-on-activation normal T cell expressed and secreted (Rantes), tumor necrosis factor alpha (TNF-α), and vascular endothelial growth factor (VEGF).
Time Frame
3 months after treatment is initiated
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dry Eye Severity Level (DESL) 1-3
Equivalent between-eye DESL
Exclusion Criteria:
Ocular infection and/or non-linked inflammation
Corneal pathology (except KSP)
Corneal refractive surgery or cataract surgery within 6 months prior to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tor P Utheim, PhD
Phone
+47 22444440
Email
utheim2@gmail.com
Facility Information:
Facility Name
The Norwegian Dry Eye Clinic
City
Oslo
ZIP/Postal Code
0366
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tor P Utheim, PhD
Phone
+47 22444440
Email
utheim2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Types of Artificial Tears
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