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:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT05931861
Eligibility Criteria:
Main Inclusion Criteria:
* Informed consent signed and dated
* Patient aged ≥ 18 years old
* Well fitted contact lenses (CL) according to the investigator judgement
* Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study
* Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18
* CLDEQ-8 score ≥ 12
Main Exclusion Criteria:
* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).
* Severe blepharitis
* Severe Meibomian gland dysfunction
* Palpebral or nasolacrimal disorders
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05931861
Study Brief:
Protocol Section:
NCT05931861