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 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06686368
Eligibility Criteria:
Inclusion Criteria:
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent form.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
* OSDI ≥ 13
* And TBUT \< 10 seconds
* And \>5 spots of corneal fluorescein staining OR \> 9 conjunctival spots
* Meibomian Gland score of 1 or higher using NEI grading criteria.
Exclusion Criteria:
* Is participating in any concurrent clinical or research study.
* Is wears contact lenses.
* Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
* Has undergone eye surgery involving the cornea or conjunctiva.
* Aqueous deficient DED patients.
* Is currently or has used any of the study drops in the last 3 months.
* Has any known allergy or intolerance to any of the study drops.
* Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease).
* Has known sensitivity to sodium fluorescein.
* Is pregnant, lactating or planning a pregnancy at the time of enrolment?
* Unwilling to stop using their habitual artificial tears for the study.
* Has been fitted with punctal plugs within 30 days before the study screening visit.
* Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06686368
Study Brief:
Protocol Section:
NCT06686368