Phase
Condition
Sjogren's Syndrome
Dry Eyes
Dry Eye Disease
Treatment
N/AClinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 and ≤ 90 at the time of informed consent
Subjects experiencing dry eye based on a global clinical assessment by the attendingclinician, subject complaint of dry eye symptoms
Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312mOsm/L in at least one eye
Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye
Exclusion
Exclusion Criteria:
Allergy to fish oil or safflower oil
Clinically significant eyelid deformity or eyelid movement disorder that is caused byconditions such as notch deformity, incomplete lid closure, entropion, ectropion,hordeola or chalazia
Previous ocular disease leaving sequelae or requiring current topical eye therapyother than for DED, including, but not limited to: active corneal or conjunctivalinfection of the eye and ocular surface scarring Active ocular or nasal allergy
LASIK or PRK surgery that was performed within one year of the Screening Visit or atany time during the study
Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitualartificial tear should be continued at the same frequency and no change in drop brand
Contact lens wear within 12 hours of any study visits
Pregnancy or lactation during the study
Abnormal nasolacrimal drainage (by history)
Punctal cauterization or punctal plug placement within 60 days of screening
Prohibited Medications - Cyclosporine (Restasis®); any topical prescriptionmedications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines ortopical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3weeks (21 days) of Screening and at any time during the study
Study Design
Connect with a study center
The Eye Center of Columbus
Columbus, Ohio 43215
United StatesSite Not Available
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