Trials / Unknown
UnknownNCT05356728
Comparison of Two Types of Artificial Tears
Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- The Norwegian Dry Eye Clinic · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
Timeline
- Start date
- 2022-03-11
- Primary completion
- 2023-06-01
- Completion
- 2023-12-01
- First posted
- 2022-05-02
- Last updated
- 2022-07-01
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT05356728. Inclusion in this directory is not an endorsement.