Comparison of Two Types of Artificial Tears

The Norwegian Dry Eye Clinic

Status: Enrolling

Conditions: Dry Eye Disease

Treatments: Drug: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05356728

Hyabak vs. Thealoz Duo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Thealoz Duo

Active Comparator group

Description:

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

Treatment:

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

Hyabak

Active Comparator group

Description:

Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily

Treatment:

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