| Participants |
Country: USA
Inclusion:
Adults at least 18 years of age at the time of the Screening Visit Willing and able to read, sign, and date the informed consent form (ICF) after the nature of the study has been explained and any questions have been answered, and prior to initiation of any study procedures or exams Willing and able to comply with all study procedures and attend all study visits Willing to suspend use of tear substitutes at least 72 hours prior to Visit 2 (Day 0) through Visit 7 (Day 98) BCVA of 0.7 log of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1 (Day −14 to Day 0) Participant‐reported history of dry eye in both eyes -
Meeting ALL of the following criteria in the same eye at Visit 1 (Day −14 to Day 0) and meeting ALL of the following criteria in the same eye at Visit 2 (Day 0) if Visit 2 is performed > 5 days after Visit 1:
minimum score of greater than or equal to 5 but less than or equal to 9 on UNC DEMS questionnaire; Schirmer tear test (with anesthesia) equal to or less than 10 mm, but more than 1 mm; TBUT: equal to or less than 5 seconds.
A negative urine pregnancy test if female and of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy, or bilateral oophorectomy] or postmenopausal [12 months after last menses] or premenarchal) and must have used adequate birth control throughout the study period (through Visit 7 [Day 98]). Adequate birth control is defined as hormonal: oral, implantable, injectable, or transdermal contraceptives; mechanical: spermicide in conjunction with a barrier such as condom or diaphragm; intrauterine device; abstinence; or surgical sterilization of male partner Patients with secondary Sjögren's syndrome (e.g. rheumatoid arthritis, systemic lupus erythematosus) or other autoimmune diseases (e.g. multiple sclerosis, inflammatory bowel disease) are eligible for study consideration provided they meet all other inclusion and exclusion criteria, AND are not in a medical state (in the opinion of the principal investigator) that could interfere with study parameters, are not taking systemic/ocular steroids, and are not immunodeficient/immunosuppressed (e.g. receiving systemic immunomodulating or immunosuppressive drugs to manage their baseline medical state)
Exclusion:
Contraindications or known hypersensitivity to the study drug(s), including Restasis or Xiidra, or their components Patients who are employees or immediate family members of employees at the investigational site Patients who are members of the same household Any ocular condition that, in the opinion of the investigator, may affect study parameters including, but not limited to, lid margin disorders (e.g. blepharitis including staphylococcal, demodex, or seborrheic; excessive lid laxity, floppy eyelid syndrome, ectropion, entropion), advanced conjunctivochalasis, Salzmann's nodular degeneration, and asthenopia‐related conditions, allergic conjunctivitis, glaucoma, diabetic retinopathy, follicular conjunctivitis, iritis, uveitis, wet‐exudative age‐related macular degeneration, retinal vein occlusion, and/or active ocular inflammation (more extensive items on ClinicalTrials.gov)
Target sample size: 280 |
