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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT05814757
Eligibility Criteria:
Inclusion Criteria:
* VAS eye dryness severity score ≥ 35 and ≤ 90 at screening.
* Investigator assessment of bulbar conjunctival hyperemia grade ≥ 2 (CCLRU; 0 - 4 scale).
* Unanesthetized Schirmer of \> 0 and ≤ 10 mm.
* Must not have used Artificial Tears during the Screening period.
* IOP in both eyes ≥ 5 mmHg and ≤21 mmHg.
Exclusion Criteria:
* Have worn contact lenses in the 4 weeks prior to the screening visit and/or are unwilling to discontinue use of contact lenses throughout the study period.
* Have a history of glaucoma or ocular hypertension or have a history of intraocular pressure (IOP) \< 5 mmHg or \> 24 mmHg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05814757
Study Brief:
Protocol Section:
NCT05814757