Comparison of Two Types of Artificial Tears

Not Applicable

• Conditions: Dry Eye Disease
• Interventions: Drug: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop

• Registration Number: NCT05356728
• Lead Sponsor: The Norwegian Dry Eye Clinic

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.

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-07-01
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thealoz Duo	Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop	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	Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop	Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily

Primary Outcome Measures

Name	Time	Method
Subjective dry eye symptoms	3 months after treatment is initiated	Ocular Surface Disease Index (OSDI) dry eye questionnaire

Secondary Outcome Measures

Name	Time	Method
Fluorescein tear film break up time	3 months after treatment is initiated	Unit: seconds
Tear film osmolarity	3 month after treatment is initiated	Unit: Osm/L
Schirmer test	3 months after treatment is initiated	Without anaesthesia, recorded as mm in length of wetting after 5min
Ocular surface staining	3 months after treatment is initiated	Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15
Meibum expressibility	1 month after treatment is initiated	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	3 months after treatment is initiated	Meibum expressibility and quality
Meibum quality	3 months after treatment is initiated	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	3 months after the treatment is initiated	Patients will be asked about which artificial tear they prefer
Luminex	3 months after treatment is initiated	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).

Trial Locations

Locations (1)

The Norwegian Dry Eye Clinic; 🇳🇴 Oslo, Norway