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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT06493604
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age (either gender and any race)
* Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Exclusion Criteria:
* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
* Previous laser-assisted in situ keratomileusis surgery within the last 12 months
* Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
* Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06493604
Study Brief:
Protocol Section:
NCT06493604