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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT05724056
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Aged ≥ 18 years
* Documented history of dry eyes and use of tear substitutes for at least 3 months within the last year
* Presence of corneal fluorescein staining (Oxford Scale, Score ≥ 2) in at least one eye
* Ocular Surface Disease Index (OSDI) ≥ 23
* Reduced tear break-up time (\< 11 seconds)
Exclusion Criteria:
* Women who are pregnant or lactating
* Best far corrected visual acuity \< 1/10 in both eyes
* Known hypersensitivity to one of the components of the study medications or test products
* Use of any ocular topical medication other than the study medications for the treatment of ocular diseases including artificial tears during the study period
* Ocular surgery (of any type, including laser surgery and punctal plugs) or ocular trauma within the 4 months prior to screening
* Active ocular infection
* Active allergies requiring treatment
* Glaucoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05724056
Study Brief:
Protocol Section:
NCT05724056