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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
One of the eyes will be assigned to use Thealoz Duo while the other with Hyabak by using randomisation table
The Norwegian Dry Eye Clinic
Oslo, Norway
RECRUITINGSubjective dry eye symptoms
McMonnies dry eye questionnaire
Time frame: Baseline,
Subjective dry eye symptoms
McMonnies dry eye questionnaire
Time frame: 1 month after treatment is initiated
Subjective dry eye symptoms
McMonnies dry eye questionnaire
Time frame: 3 months after treatment is initiated
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time frame: Baseline
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time frame: 1 month after treatment is initiated
Subjective dry eye symptoms
Ocular Surface Disease Index (OSDI) dry eye questionnaire
Time frame: 3 months after treatment is initiated
Fluorescein tear film break up time
Unit: seconds
Time frame: Baseline
Fluorescein tear film break up time
Unit: seconds
Time frame: 1 month after treatment is initiated
Fluorescein tear film break up time
Unit: seconds
Time frame: 3 months after treatment is initiated
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Time frame: Baseline
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Time frame: 1 month after treatment is initiated
Schirmer test
Without anaesthesia, recorded as mm in length of wetting after 5min
Time frame: 3 months after treatment is initiated
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time frame: Baseline
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time frame: 1 month after treatment is initiated
Ocular surface staining
Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Time frame: 3 months after treatment is initiated
Tear film osmolarity
Unit: Osm/L
Time frame: Baseline
Tear film osmolarity
Unit: Osm/L
Time frame: 1 month after treatment is initiated
Tear film osmolarity
Unit: Osm/L
Time frame: 3 month after treatment is initiated
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
Time frame: Baseline
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
Time frame: 1 month after treatment is initiated
Meibomian gland functionality
Meibum expressibility and quality
Time frame: 3 months after treatment is initiated
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
Time frame: Baseline
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
Time frame: 1 month after treatment is initiated
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
Time frame: 3 months after treatment is initiated
Patient´s subjective evaluation of preference
Patients will be asked about which artificial tear they prefer
Time frame: 1 month after the treatment is initiated
Patient´s subjective evaluation of preference
Patients will be asked about which artificial tear they prefer
Time frame: 3 months after the treatment is initiated
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).
Time frame: Baseline
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).
Time frame: 1 month after treatment is initiated
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).
Time frame: 3 months after treatment is initiated
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