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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT06058559
Eligibility Criteria:
Inclusion Criteria:
* Age greater than18 at the time of informed consent
* Clinical diagnosis of dry eye in both eyes
* Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
* The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
* Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
* Patient Evaluation of Eye Dryness (SPEED) questionnaire score \>6 to \<14
* Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
Exclusion Criteria:
* Any pre-existing ocular disease other than dry eye disease
* Patients with inability to swallow soft gel capsules
* Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
* Drastic change of food and/or food supplements within the last month.
* Other food supplement with fatty acids
* Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.
* Ocular surgery within the last 6 months.
* Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.
* Occlusion therapy with lacrimal or punctum plugs within the last 3 months.
* Alterations of the lacrimal drainage system
* Eyelid abnormalities
* Patients on oral tetracycline or corticosteroids
* Active allergy or infection at the ocular surface
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06058559
Study Brief:
Protocol Section:
NCT06058559