Comparison of Two Types of Artificial Tears

Dry Eye Disease Clinical Trial

Official title:

Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356728
• Other study ID #: Hyabak vs. Thealoz Duo
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: The Norwegian Dry Eye Clinic
• Contact: Tor P Utheim, PhD
• Phone: +47 22444440
• Email: utheim2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop
One of the eyes will be assigned to use Thealoz Duo while the other with Hyabak by using randomisation table

Locations

Country	Name	City	State
Norway	The Norwegian Dry Eye Clinic	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
The Norwegian Dry Eye Clinic	Laboratoires Thea

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective dry eye symptoms	McMonnies dry eye questionnaire	Baseline,
Primary	Subjective dry eye symptoms	McMonnies dry eye questionnaire	1 month after treatment is initiated
Primary	Subjective dry eye symptoms	McMonnies dry eye questionnaire	3 months after treatment is initiated
Primary	Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	Baseline
Primary	Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	1 month after treatment is initiated
Primary	Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	3 months after treatment is initiated
Secondary	Fluorescein tear film break up time	Unit: seconds	Baseline
Secondary	Fluorescein tear film break up time	Unit: seconds	1 month after treatment is initiated
Secondary	Fluorescein tear film break up time	Unit: seconds	3 months after treatment is initiated
Secondary	Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	Baseline
Secondary	Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	1 month after treatment is initiated
Secondary	Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	3 months after treatment is initiated
Secondary	Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	Baseline
Secondary	Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	1 month after treatment is initiated
Secondary	Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	3 months after treatment is initiated
Secondary	Tear film osmolarity	Unit: Osm/L	Baseline
Secondary	Tear film osmolarity	Unit: Osm/L	1 month after treatment is initiated
Secondary	Tear film osmolarity	Unit: Osm/L	3 month after treatment is initiated
Secondary	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	Baseline
Secondary	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	1 month after treatment is initiated
Secondary	Meibomian gland functionality	Meibum expressibility and quality	3 months after treatment is initiated
Secondary	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	Baseline
Secondary	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	1 month after treatment is initiated
Secondary	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	3 months after treatment is initiated
Secondary	Patient´s subjective evaluation of preference	Patients will be asked about which artificial tear they prefer	1 month after the treatment is initiated
Secondary	Patient´s subjective evaluation of preference	Patients will be asked about which artificial tear they prefer	3 months after the treatment is initiated
Secondary	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-?), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1a (MIP-1a/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-a), and vascular endothelial growth factor (VEGF).	Baseline
Secondary	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-?), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1a (MIP-1a/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-a), and vascular endothelial growth factor (VEGF).	1 month after treatment is initiated
Secondary	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-?), interferon gamma-induced protein 10 (IP-10), monocyte chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1a (MIP-1a/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-a), and vascular endothelial growth factor (VEGF).	3 months after treatment is initiated