Comparison of Two Types of Artificial Tears

Last updated: June 27, 2022
Sponsor: The Norwegian Dry Eye Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sjogren's Syndrome

Dry Eyes

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT05356728
Hyabak vs. Thealoz Duo
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 96
Study Start date:
March 11, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • The Norwegian Dry Eye Clinic

    Oslo, 0366
    Norway

    Active - Recruiting

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