Comparison of Two Types of Artificial Tears

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tor P Utheim, PhD; Phone Number: +47 22444440; Email: utheim2@gmail.com

Study Locations

• Norway
  • Oslo, Norway, 0366
    • Recruiting
    • The Norwegian Dry Eye Clinic
    • Contact: Tor P Utheim, PhD; Phone Number: +47 22444440; Email: utheim2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thealoz Duo; 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	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
Active Comparator: Hyabak; Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective dry eye symptoms	McMonnies dry eye questionnaire	Baseline,
Subjective dry eye symptoms	McMonnies dry eye questionnaire	1 month after treatment is initiated
Subjective dry eye symptoms	McMonnies dry eye questionnaire	3 months after treatment is initiated
Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	Baseline
Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	1 month after treatment is initiated
Subjective dry eye symptoms	Ocular Surface Disease Index (OSDI) dry eye questionnaire	3 months after treatment is initiated

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein tear film break up time	Unit: seconds	Baseline
Fluorescein tear film break up time	Unit: seconds	1 month after treatment is initiated
Fluorescein tear film break up time	Unit: seconds	3 months after treatment is initiated
Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	Baseline
Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	1 month after treatment is initiated
Schirmer test	Without anaesthesia, recorded as mm in length of wetting after 5min	3 months after treatment is initiated
Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	Baseline
Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	1 month after treatment is initiated
Ocular surface staining	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15	3 months after treatment is initiated
Tear film osmolarity	Unit: Osm/L	Baseline
Tear film osmolarity	Unit: Osm/L	1 month after treatment is initiated
Tear film osmolarity	Unit: Osm/L	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	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	1 month after treatment is initiated
Meibomian gland functionality	Meibum expressibility and quality	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	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	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	3 months after treatment is initiated
Patient´s subjective evaluation of preference	Patients will be asked about which artificial tear they prefer	1 month after the treatment is initiated
Patient´s subjective evaluation of preference	Patients will be asked about which artificial tear they prefer	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).	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).	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).	3 months after treatment is initiated

Collaborators and Investigators

• Sponsor: The Norwegian Dry Eye Clinic
• Collaborators: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Hyabak vs. Thealoz Duo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No