Comparison of Two Types of Artificial Tears

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The doctors who examine the patients will not get any information about the choice of artificial tears in each eye.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Hyabak

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No