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

Recruiting

• Conditions: Dry Eye Disease (DED)

• Registration Number: NCT07007702
• Lead Sponsor: Laboratoires Thea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-27
• Study First Submitted: 2025-04-17
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Ophthalmic 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

Systemic / non ophthalmic exclusion criteria:

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

Specific exclusion criteria for women:

• 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)

Exclusion criteria related to general conditions

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis	at week 12	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"
Conjunctival hyperaemia assesment with Efron scale at week 12	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

Trial Locations

Locations (1)

Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien; 🇦🇹 Wien, Austria