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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04498169
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 years or older
2. Documented diagnosis of FCD
3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)
Exclusion Criteria:
1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04498169
Study Brief:
Protocol Section:
NCT04498169