Clinical trial NCT07007702: Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease
Official title: Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease (DED)
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients with moderate to severe dry eye disease and associated inflammation.

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.


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:

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

Primary outcomes:
measure: Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis
timeFrame: at week 12
measure: Conjunctival hyperaemia assesment with Efron scale at week 12
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien
Study officials:
References: