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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05501860
Eligibility Criteria:
Inclusion Criteria:
1. Provide written informed consent prior to any study-related procedures being performed.
2. Male or a non-pregnant, non-lactating female.
3. Healthy by clinical assessment, including ocular examination.
4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.
Specular microscopy subset subjects only:
6. Have a central corneal endothelial cell density of ā„1500 cells/mm2 at baseline
Exclusion Criteria:
1. . Have participated in an investigational study within the past 30 days.
2. Have a contraindication to local anesthetics, SeptocaineĀ®, or any component of the IMP.
3. Have had ocular surgery or general surgery in either eye within the past 90 days.
4. Have had an intravitreal injection in either eye within 14 days of randomization.
5. Have ocular surface disease requiring punctal plugs.
6. Have evidence of any current ocular inflammation.
7. Current ocular allergy symptoms.
8. Have used topical, ocular medications in the 24 hours preceding dosing.
9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
10. Previous participation in a clinical study of AG-920.
11. A current condition which could cause vision problems such as Pseudotumor Cerebri.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05501860
Study Brief:
Protocol Section:
NCT05501860