Clinical trial NCT05356728: Comparison of Two Types of Artificial Tears
Official title: Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: The Norwegian Dry Eye Clinic
Sponsor class: OTHER_GOV
Collaborators: name: Laboratoires Thea
First posted: 2022-05-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective dry eye symptoms
timeFrame: Baseline,
measure: Subjective dry eye symptoms
timeFrame: 1 month after treatment is initiated
measure: Subjective dry eye symptoms
timeFrame: 3 months after treatment is initiated
measure: Subjective dry eye symptoms
timeFrame: Baseline
measure: Subjective dry eye symptoms
timeFrame: 1 month after treatment is initiated
measure: Subjective dry eye symptoms
timeFrame: 3 months after treatment is initiated
Secondary outcomes:
measure: Fluorescein tear film break up time
timeFrame: Baseline
measure: Fluorescein tear film break up time
timeFrame: 1 month after treatment is initiated
measure: Fluorescein tear film break up time
timeFrame: 3 months after treatment is initiated
measure: Schirmer test
timeFrame: Baseline
measure: Schirmer test
timeFrame: 1 month after treatment is initiated
measure: Schirmer test
timeFrame: 3 months after treatment is initiated
measure: Ocular surface staining
timeFrame: Baseline
measure: Ocular surface staining
timeFrame: 1 month after treatment is initiated
measure: Ocular surface staining
timeFrame: 3 months after treatment is initiated
measure: Tear film osmolarity
timeFrame: Baseline
measure: Tear film osmolarity
timeFrame: 1 month after treatment is initiated
measure: Tear film osmolarity
timeFrame: 3 month after treatment is initiated
measure: Meibum expressibility
timeFrame: Baseline
measure: Meibum expressibility
timeFrame: 1 month after treatment is initiated
measure: Meibomian gland functionality
timeFrame: 3 months after treatment is initiated
measure: Meibum quality
timeFrame: Baseline
measure: Meibum quality
timeFrame: 1 month after treatment is initiated
measure: Meibum quality
timeFrame: 3 months after treatment is initiated
measure: Patient´s subjective evaluation of preference
timeFrame: 1 month after the treatment is initiated
measure: Patient´s subjective evaluation of preference
timeFrame: 3 months after the treatment is initiated
measure: Luminex
timeFrame: Baseline
measure: Luminex
timeFrame: 1 month after treatment is initiated
measure: Luminex
timeFrame: 3 months after treatment is initiated
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: The Norwegian Dry Eye Clinic
Study officials:
References: