Dry Eye Disease
Conditions
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.
Interventions
DRUGThealoz 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
Sponsors
Laboratoires Thea
The Norwegian Dry Eye Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The doctors who examine the patients will not get any information about the choice of artificial tears in each eye.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective dry eye symptoms | Baseline, | McMonnies dry eye questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meibum quality | Baseline | 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 |
| Fluorescein tear film break up time | Baseline | Unit: seconds |
| Schirmer test | Baseline | Without anaesthesia, recorded as mm in length of wetting after 5min |
| Ocular surface staining | Baseline | Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15 |
| Tear film osmolarity | Baseline | Unit: Osm/L |
| Meibum expressibility | Baseline | 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 |
| Patient´s subjective evaluation of preference | 1 month after the treatment is initiated | Patients will be asked about which artificial tear they prefer |
| Luminex | Baseline | 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). |
Countries
Norway
Contacts
Primary ContactTor P Utheim, PhD
Outcome results
None listed