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

NCT07007702 | Completed

• 1 other identifier: LT2769-005
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis

  Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS: "I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"

  at week 12

• Conjunctival hyperaemia assesment with Efron scale at week 12

  Conjunctival hyperemia grading with Photographs (Efron) scale at week 12 * Descriptive analysis * Cross table baseline vs week 12; McNemar Bowker (0) = None 1. = Trace 2. = Mild 3. = Moderate 4. = Severe

  week 12

Study Arms (1)

Group receiving T2769

Device: T2769

Interventions

T2769 DEVICE

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

Group receiving T2769

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 30 patients with moderate to severe dry eye disease and associated inflammation.

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (1)

Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien

Vienna, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Schirmer test strips stored for proteomics and lipidomics analysis

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: June 6, 2025
• Study Start: January 27, 2025
• Primary Completion: April 28, 2025
• Study Completion: June 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

AU (1)