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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01998802
Eligibility Criteria:
Inclusion Criteria:
* Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
* Are ≥ 18 years of age;
* Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
* Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
* Have normal lid anatomy.
* If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1
Exclusion Criteria:
* Have signs of infection (i.e., fever or current treatment with antibiotics)
* Have been exposed to an investigational drug/device within the preceding 30 days
* Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
* Be unwilling to or unable to comply with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01998802
Study Brief:
Protocol Section:
NCT01998802