Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT07234318
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* No patients with other ophthalmic diseases than DED
* Chronic dry eye defined as longer than six months since diagnosis
* OSDI score \> 22
* Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)
* Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician
* Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician
Exclusion Criteria:
Ophthalmic exclusion criteria
* Far best corrected visual acuity \< 1/10
* Severe Dry Eye associated with:
* Eyelid malposition
* Stevens Johnson Syndrome
* Corneal dystrophy
* Ocular neoplasia
* Filamentous keratitis
* Corneal neovascularisation
* Orbital radiotherapy
* Dry eye related to Graft Versus Host Disease (GVHD)
* History of any of the following within last 3 months:
* Systemic treatment of dry eye
* Systemic treatment of Meibomian Gland Dysfunction (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 product 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 with spermicide)
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07234318
Study Brief:
Protocol Section:
NCT07234318