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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT02078661
Eligibility Criteria:
Inclusion Criteria:
* Be male or female of any race, at least 18 years of age
* Have provided verbal and written informed consent
* Be able and willing to follow instructions, including participation in all study assessments and visits
* Have a reported history of dry eye syndrome
* Have a history of use or desire to use eye drops for dry eye
* If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period
* Have a best corrected visual acuity of +0.70 logMAR or better in both eyes
Exclusion Criteria:
* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1
* Be a woman who is pregnant, nursing or planning a pregnancy
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02078661
Study Brief:
Protocol Section:
NCT02078661