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

Thea Pharma

Status: Completed

Conditions: Dry Eye Disease (DED)

Treatments: Device: T2769

Study type: Observational

Funder types: Industry

Identifiers

NCT07007702

LT2769-005

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Group receiving T2769

Treatment:

Device: T2769