NCT05356728

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

April 20, 2022

Last Update Submit

June 27, 2022

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (23)

  • Fluorescein tear film break up time

    Baseline

  • Fluorescein tear film break up time

    1 month after treatment is initiated

  • Fluorescein tear film break up time

    3 months after treatment is initiated

  • Schirmer test

    Baseline

  • Schirmer test

    1 month after treatment is initiated

  • +18 more secondary outcomes

Study Arms (2)

Thealoz Duo

ACTIVE COMPARATOR

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

Hyabak

ACTIVE COMPARATOR

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

Interventions

Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye dropDRUG

One of the eyes will be assigned to use Thealoz Duo while the other with Hyabak by using randomisation table

HyabakThealoz Duo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dry Eye Severity Level (DESL) 1-3
  • Equivalent between-eye DESL

You may not qualify if:

  • Ocular infection and/or non-linked inflammation
  • Corneal pathology (except KSP)
  • Corneal refractive surgery or cataract surgery within 6 months prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Norwegian Dry Eye Clinic

Oslo, 0366, Norway

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Central Study Contacts

Tor P Utheim, PhD

CONTACT

+47 22444440utheim2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The doctors who examine the patients will not get any information about the choice of artificial tears in each eye.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 2, 2022

Study Start

March 11, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)