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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT05370495
Eligibility Criteria:
* Inclusion Criteria
1. Provide written informed consent prior to any study-related procedures.
2. Are 18 years of age or older.
3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
4. Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.
Exclusion Criteria:
1. Unanesthetized Schirmer test score in either eye \<2 mm/5 minutes at Visit 1.
2. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
3. Have corneal erosive disease (e.g., confluent staining \[National Eye Institute (NEI) grade 4\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
4. Have a history of glaucoma or intraocular pressure (IOP) \>25 mmHg at Visit 1 or a history of elevated IOP (\>25 mmHg) in either eye.
5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05370495
Study Brief:
Protocol Section:
NCT05370495