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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02617667
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
* Patient-reported history of dry eye in both eyes
* Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
* Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria:
* Women who are pregnant, nursing or planning a pregnancy
* Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* DED secondary to scarring or ocular or periocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study period
* Ongoing ocular or systemic infection at screening or baseline
* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
* History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
* Presence of an uncontrolled systemic disease
* Presence of a known allergy and/or sensitivity to the study drug or its components
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02617667
Study Brief:
Protocol Section:
NCT02617667