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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT03319420
Eligibility Criteria:
Inclusion Criteria:
* Male or female of any race and ≥ 18 years of age.
* Willing and able to provide voluntary written informed consent.
* Primary or secondary Sjögren's syndrome according to the American- European Consensus Classification Criteria (2002).
* Females of childbearing potential must agree to use effective contraception consistently throughout the study (such as hormonal contraception or two forms of barrier contraception) and have a negative urine pregnancy test at screening.
* Willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
* Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk.
* Subjects with pterygium.
* Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
* Subjects with blepharitis requiring treatment.
* Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
* Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
* Female subjects who are pregnant or breast-feeding, or plan to become pregnant during the study.
* Subjects that have started or changed the dose of chronic systemic medication within 7 days of Visit 1.
* Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981) or any of the components in Systane Ultra UD.
* Active abuse of alcohol or drugs.
* Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT03319420
Study Brief:
Protocol Section:
NCT03319420