Comparison of Two Types of Artificial Tears

Sponsor
The Norwegian Dry Eye Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05356728
Collaborator
Laboratoires Thea (Industry)
96
1
2
20.7
4.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease
Actual Study Start Date :
Mar 11, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Subjective dry eye symptoms [Baseline,]

    McMonnies dry eye questionnaire

  2. Subjective dry eye symptoms [1 month after treatment is initiated]

    McMonnies dry eye questionnaire

  3. Subjective dry eye symptoms [3 months after treatment is initiated]

    McMonnies dry eye questionnaire

  4. Subjective dry eye symptoms [Baseline]

    Ocular Surface Disease Index (OSDI) dry eye questionnaire

  5. Subjective dry eye symptoms [1 month after treatment is initiated]

    Ocular Surface Disease Index (OSDI) dry eye questionnaire

  6. Subjective dry eye symptoms [3 months after treatment is initiated]

    Ocular Surface Disease Index (OSDI) dry eye questionnaire

Secondary Outcome Measures

  1. Fluorescein tear film break up time [Baseline]

    Unit: seconds

  2. Fluorescein tear film break up time [1 month after treatment is initiated]

    Unit: seconds

  3. Fluorescein tear film break up time [3 months after treatment is initiated]

    Unit: seconds

  4. Schirmer test [Baseline]

    Without anaesthesia, recorded as mm in length of wetting after 5min

  5. Schirmer test [1 month after treatment is initiated]

    Without anaesthesia, recorded as mm in length of wetting after 5min

  6. Schirmer test [3 months after treatment is initiated]

    Without anaesthesia, recorded as mm in length of wetting after 5min

  7. Ocular surface staining [Baseline]

    Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15

  8. Ocular surface staining [1 month after treatment is initiated]

    Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15

  9. Ocular surface staining [3 months after treatment is initiated]

    Fluorescein staining at the conjunctiva and cornea. Recorded using oxford scheme, range 0-15

  10. Tear film osmolarity [Baseline]

    Unit: Osm/L

  11. Tear film osmolarity [1 month after treatment is initiated]

    Unit: Osm/L

  12. Tear film osmolarity [3 month after treatment is initiated]

    Unit: Osm/L

  13. 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

  14. 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

  15. Meibomian gland functionality [3 months after treatment is initiated]

    Meibum expressibility and quality

  16. 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

  17. Meibum quality [1 month 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

  18. 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

  19. Patient´s subjective evaluation of preference [1 month after the treatment is initiated]

    Patients will be asked about which artificial tear they prefer

  20. Patient´s subjective evaluation of preference [3 months after the treatment is initiated]

    Patients will be asked about which artificial tear they prefer

  21. 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).

  22. Luminex [1 month 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).

  23. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Norwegian Dry Eye Clinic Oslo Norway 0366

Sponsors and Collaborators

  • The Norwegian Dry Eye Clinic
  • Laboratoires Thea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Norwegian Dry Eye Clinic
ClinicalTrials.gov Identifier:
NCT05356728
Other Study ID Numbers:
  • Hyabak vs. Thealoz Duo
First Posted:
May 2, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022