Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease

NCT ID: NCT07007702

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2025-06-30

Brief Summary

The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.

The main question it aims to answer is:

• To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.

Participants will be asked to use T2769 on a daily basis.

Conditions

Dry Eye Disease (DED)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group receiving T2769

T2769

Intervention Type: DEVICE

Preservative-free combination of trehalose, sodium hyaluronate and N-Acetyl Aspartyl Glutamic Acid

Interventions

T2769

Preservative-free combination of trehalose, sodium hyaluronate and N-Acetyl Aspartyl Glutamic Acid

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Normal ophthalmic findings except dry eye disease
• Chronic dry eye defined as longer than six months since diagnosis
• OSDI ≥ 22
• Conjunctival Hyperemia≥ Grade 3 (Efron Scale)
• Current use of topical lubricants since at least 3 months

Exclusion Criteria

• Best far corrected visual acuity < 1/10
• Severe Dry Eye associated with:

• Eyelid malposition
• Sjogren Syndrome
• Stevens Johnson Syndrome
• Corneal dystrophy
• Ocular neoplasia
• Filamentous keratitis
• Corneal neovascularisation
• Orbital radiotherapy
• Dry eye related to GVHD
• History of any of the following within last 3 months:
• Systemic treatment of dry eye
• Systemic treatment of MGD
• Isotretinoïde,
• Cyclosporine,
• Tacrolimus, Siromilus, Pimecrolimus
• Punctual plugs
• History of any of the following within previous six months:
• ocular trauma
• ocular infection, Ocular allergy
• History of any of the following within last 12 months:
• inflammatory corneal ulcer
• Herpetic eye infection
• or uveitis
• Ocular surgery

• Known hypersensitivity to any of the components of the medical device under investigation or other study medication

• Pregnant or breast-feeding woman.
• Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms)

• Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.
• Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
• Participation in another clinical study or clinical investigation at the same time as the present investigation
• Participation to the present clinical investigation during the exclusion period of another clinical study
• Patient already included once in this clinical investigation
• Patient under guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires Thea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien

Vienna, , Austria

Countries

Austria

Other Identifiers

LT2769-005

Identifier Type: -

Identifier Source: org_study_id